Label: ATONO2 OXYGEN BABY SOOTHING GEL- glycerin gel
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 13, 2016
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- For external use only
- When using this product
1. If any one of following symptoms occurs when using cosmetics, stop using it and consult a dermatologist.
A. red spot, swelling, itching, stimulus
B. symptoms mentioned above are caused by sunlight.
2. Do not apply on skin where there is wound, eczema, or irritation.
3. Storage and cautions for handling
A. Close stopper after using.
B. Keep out of reach of children.
C. Keep away from high or low temperature and direct sunlight.
4. This is not a medicinal product. Made of 100% cosmetic ingredients, it is a sensitive-skin care product for all skin types.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ATONO2 OXYGEN BABY SOOTHING GEL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70993-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 11.985 g in 100 g Inactive Ingredients Ingredient Name Strength BETAINE (UNII: 3SCV180C9W) WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70993-0010-1 160 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 09/01/2015 Labeler - LAORGANIC Co., Ltd. (689844148) Registrant - LAORGANIC Co., Ltd. (689844148) Establishment Name Address ID/FEI Business Operations LAORGANIC Co., Ltd. 689844148 manufacture(70993-0010)