Label: ACNE WIPES- salicylic acid swab
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Contains inactivated NDC Code(s)
NDC Code(s): 55310-003-01, 55310-003-02 - Packager: Shanghai Yinjing Medical Supplies 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 July 20, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only.
Ask a doctor or pharmacist before use if you ar eusing other topical acne
medications at the same time or immediately following use of this product.
When using this product
-skin irritation and dryness is more likely to occur if you use another
topical acne medication at the same time. If irritation occurs,
only use one topical acne medication at a time.
-avoid contact with eyes. If contact occurs, flush thoroughly with water.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
-use daily to get clear skin.
-clean the skin thoroughly before applying this product.
-cover the entire affected area one to three times daily.
-because excessive drying of the skinmay occur, start with one
application daily, then gradually increase to two or three times daily
if needed or as directed by a doctor.
-if bothersome dryness or peeling occurs, reduce application to once
a day or every other day.
-throw away cloth (do not flush).
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE WIPES
salicylic acid swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55310-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID .5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) polysorbate 20 (UNII: 7T1F30V5YH) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55310-003-02 30 in 1 BAG 07/20/2016 1 NDC:55310-003-01 .5 mL in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/20/2016 Labeler - Shanghai Yinjing Medical Supplies Co., Ltd. (530501535)
