Label: ATOPIC HEALER SYNERGY- atopic healer oil
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Contains inactivated NDC Code(s)
NDC Code(s): 70470-1013-5 - Packager: PHYTOPIA CO., LTD.
- 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.
Drug Label Information
Updated October 24, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- WARNINGS
- Stretch Marks Remover
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INGREDIENTS AND APPEARANCE
ATOPIC HEALER SYNERGY
atopic healer oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70470-1013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BALSAM PERU OIL (UNII: DIK0395679) (BALSAM PERU OIL - UNII:DIK0395679) BALSAM PERU OIL 3.6 mg in 50 mL COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 4.9 mg in 50 mL Inactive Ingredients Ingredient Name Strength EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) BERGAMOT OIL (UNII: 39W1PKE3JI) TANSY OIL (UNII: 43J2812KE1) HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K) OLIVE OIL (UNII: 6UYK2W1W1E) TAMANU OIL (UNII: JT3LVK84A1) Product Characteristics Color brown (50ml per bottle) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70470-1013-5 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 04/01/2016 Labeler - PHYTOPIA CO., LTD. (656940504) Registrant - PHYTOPIA CO., LTD. (656940504) Establishment Name Address ID/FEI Business Operations PHYTOPIA CO., LTD. 656940504 manufacture(70470-1013)