1. Products & Orders
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We sell personal hygiene products: fluoride toothpaste (OTC drug), tooth powder, shampoo bars, facial masks, eye masks, and eye mask sticks.
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Prices in USD. We may correct errors or change prices.
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Product images are illustrative; actual colors, scents, and packaging may vary.
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You must be at least 18 years old to purchase.
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We may cancel orders due to inventory limits, pricing errors, or suspected fraud.
2. Regulatory Compliance & Product Classification
| Product | Classification | Key Compliance Requirements |
|---|---|---|
| Fluoride toothpaste (with anti‑cavity claim) | OTC Drug (21 CFR Part 355) | FDA registration, OTC monograph compliance, Drug Facts labeling, cGMPs |
| Shampoo bars, facial masks, non‑therapeutic tooth powder | Cosmetic | MoCRA: facility registration, product listing, safety substantiation, 21 CFR 701 labeling |
| Eye masks, eye mask sticks (fabric‑based) | General Consumer Product (CPSC) | 16 CFR Part 1610 (flammability), GCC, small parts warnings if applicable |
| Electronic eye mask sticks | FCC‑regulated | FCC Part 15B (SDoC) or Part 15C (FCC ID) |
3. Safety & Compliance
For OTC Drug Products (Fluoride Toothpaste):
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Use only as directed on the Drug Facts label. Do not swallow.
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For children under 6 years, use a pea‑sized amount under adult supervision.
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If more than used for brushing is accidentally swallowed, contact a Poison Control Center immediately.
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Keep out of reach of children under 6 years of age.
For Cosmetic Products (Shampoo Bars, Facial Masks, Tooth Powder):
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For external use only unless otherwise specified. Do not ingest.
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Discontinue use if rash, redness, or itching occurs.
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Keep out of reach of children.
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Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
For Eye Masks & Eye Mask Sticks (Fabric‑Based, CPSC-Regulated):
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For external use only. Not for ingestion.
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Keep away from open flames and high heat sources. Fabric complies with 16 CFR Part 1610 (Class 1 normal flammability).
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Not intended for use by children under 3 without adult supervision.
4. Adverse Event Reporting (MoCRA)
Under MoCRA, we are required to report serious adverse events associated with cosmetic products to FDA within 15 business days. A serious adverse event includes: death, life‑threatening experience, inpatient hospitalization, persistent disability, birth defect, infection, or significant disfigurement. If you experience such an event, contact us immediately. We will submit the report via MedWatch Form 3500A.
5. General Certificate of Conformity (GCC)
For general consumer products (eye masks, eye mask sticks) subject to CPSC safety rules, we provide a General Certificate of Conformity (GCC) available upon request.
6. Children‘s Product Certificate (CPC)
If any eye mask product is intended for children 12 and under, we provide a Children’s Product Certificate (CPC) based on third‑party testing at a CPSC‑accepted laboratory, including CPSIA lead (<100 ppm substrate, ≤90 ppm coating), phthalates (<0.1%), and 16 CFR Part 1130 tracking labels on product and packaging.