Label: DAMOAE THERAPY TONIC- salicylic acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 76081-020-01 - Packager: DUALLIFE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 6, 2012
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
WARNINGS:
If side-effects, such as redness, itching or swelling occur, discontinue use. If airritation continues after discontinuing use, consult a dermatologist.
1. If a red area develops using this product or there is swelling or itchyness, consult a dermatologist.
2. Exposure to direct sunlight may cause side-effects as above.
3. Do not apply product to an area of skin that is affected by eczema or dermatitis.
4. Wash eyes immediately and thoroughly if product enters eyes. - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAMOAE THERAPY TONIC
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76081-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2.4 mL in 120 mL Inactive Ingredients Ingredient Name Strength LEVOMENTHOL (UNII: BZ1R15MTK7) FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC) OENOTHERA BIENNIS (UNII: 76UI55V071) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEPPERMINT OIL (UNII: AV092KU4JH) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76081-020-01 120 mL in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 09/01/2011 Labeler - DUALLIFE CO., LTD. (690403832) Registrant - DUALLIFE CO., LTD. (690403832) Establishment Name Address ID/FEI Business Operations DUALLIFE CO., LTD. 690403832 manufacture