FAQ
1. How long does shipping take to the USA?
Processing: 1-3 business days. Shipping: 5-10 business days (contiguous US). You will receive tracking via email.
2. What are your shipping costs?
Calculated at checkout based on weight/destination. Free standard shipping on orders over $[amount].
3. Do you ship outside the contiguous USA?
Currently, we only ship to addresses within the contiguous 48 United States.
4. How are your products regulated by the FDA?
| Product | Classification | Key Requirements |
|---|---|---|
| Fluoride Toothpaste (anti-cavity claim) | OTC Drug | OTC monograph compliance (21 CFR Part 333), Drug Facts labeling, active ingredient standards (e.g., sodium fluoride 0.243% / 0.14% w/v fluoride ion), GMPs |
| Tooth Powder (non‑therapeutic) | Cosmetic (or OTC Drug if therapeutic claim is made) | Cosmetic: MoCRA facility registration, product listing, 21 CFR Part 701 labeling |
| Shampoo Bars, Facial Masks | Cosmetic | MoCRA: facility registration, product listing, safety substantiation, adverse event reporting, 21 CFR Part 701 labeling |
| Eye Masks & Eye Mask Sticks (fabric‑based) | General Consumer Product (CPSC) | 16 CFR Part 1610 (flammability), GCC, small parts warnings if applicable, CA Prop 65 warnings |
Fluoride Content Requirements (FDA) : For an anti-cavity claim, fluoride toothpaste must contain fluoride between 0.1% – 0.15% (850 – 1,500 ppm) depending on formulation.
5. Do your OTC drug products (toothpaste) require FDA registration?
Yes. Facilities manufacturing OTC drugs must register with FDA and list their products in the FDA drug database. We comply with all OTC monograph requirements for fluoride toothpaste, including Drug Facts labeling.
6. Are your cosmetic products registered under MoCRA?
Yes. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), our cosmetic products (shampoo bars, facial masks, non‑therapeutic toothpaste) are produced in FDA‑registered facilities. Product listings include ingredients, brand names, and product categories.
7. What are the labeling requirements for your products?
Our cosmetic products comply with 21 CFR Part 701 (Cosmetic Labeling):
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Identity statement (what the product is);
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Net quantity of contents (weight or volume);
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Ingredient declaration in descending order of predominance (21 CFR 701.3);
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Name and place of business of manufacturer, packer, or distributor (21 CFR 701.12);
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Warning statements (as applicable);
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Country of origin.
Our OTC drug products (fluoride toothpaste) include the Drug Facts panel with active ingredients, uses, warnings, directions, and inactive ingredients.
8. What are your flammability standards for eye masks?
Our fabric eye masks comply with 16 CFR Part 1610 (Standard for the Flammability of Clothing Textiles). Textiles are classified into three classes:
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Class 1 (Normal Flammability): Acceptable for use in clothing – burn time ≥3.5 seconds for plain surface fabrics.
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Class 2 (Intermediate Flammability): Applicable only to raised‑fiber surfaces.
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Class 3 (Rapid and Intense Burning): Burn time <3.5 seconds – banned from use in clothing. Class 3 textiles would require a “FLAMMABLE” warning label.
Our eye masks are Class 1 compliant and meet CPSC requirements, but please keep them away from open flames.
9. What is the General Certificate of Conformity (GCC)?
For general consumer products (eye masks, eye mask sticks) that are subject to CPSC safety rules (including 16 CFR Part 1610 for textile flammability), we provide a General Certificate of Conformity (GCC) available upon request. The GCC certifies compliance with applicable CPSC safety rules based on testing or a reasonable testing program. The GCC includes: product identification, citation to each CPSC product safety rule, manufacturer/importer information, date and place of manufacture, testing dates, and record‑keeper contact.
10. Do your eye masks have small parts that could be a choking hazard?
If any product contains detachable small parts (e.g., adjustable straps, buckles, beads) and is intended for children aged 3‑8, the packaging includes the following warning per 16 CFR § 1500.19:
⚠ WARNING: CHOKING HAZARD – Small parts. Not for children under 3 years.
Our eye masks are designed for adult use. However, we include appropriate warnings where applicable.
11. Do your cosmetic products have tamper‑evident packaging?
Yes. Our liquid and cream cosmetic products meet the tamper‑resistant packaging requirements of 21 CFR 700.25, which requires an indicator or barrier to entry that is distinctive by design. The FDA requires a labeling statement on the package indicating the tamper‑evident feature (e.g., "For your protection, this product has a sealed neck band.")
12. What is the shelf life of your products?
Most products have a shelf life of 2-3 years when stored in a cool, dry place away from direct sunlight. Check the "best by" date on the packaging. Once opened, refer to the Period After Opening (PAO) symbol (e.g., "12M" = use within 12 months after opening).
13. What if I have an allergic reaction or other adverse event?
Discontinue use immediately. If you experience a serious adverse event (defined by FDA as: death, life‑threatening experience, inpatient hospitalization, persistent disability, birth defect, infection, or significant disfigurement), we are required under MoCRA to report the event to FDA within 15 business days using MedWatch Form 3500A. Please contact us immediately with:
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Product name and batch/lot number;
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Photos of the reaction (if applicable);
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Date of reaction and medical treatment received (if any).
For non‑serious reactions, please still report them to us so we can monitor product safety and improve formulations.
14. What is California Proposition 65?
Some products may contain chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm (e.g., certain preservatives, fragrances, or heavy metals that may naturally occur in botanical ingredients). Proposition 65 warnings are required if exposure exceeds safe harbor levels. When applicable, a clear and reasonable warning will be displayed on product pages and packaging. The presence of a Prop 65 warning does not mean the product is unsafe; it is a disclosure required under California law.
15. What payment methods do you accept?
Visa, Mastercard, Amex, Discover, PayPal, Apple Pay.