Label: ADVANCED ACNE SPOT TREATMENT- salicylic acid gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 58194-030-01 - Packager: Shanghai Weierya Daily Chemicals Factory
- 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 January 10, 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
-
WARNINGS
Warnings
For external use only.
Flammable. Keep away from fire or flame.
Ask a doctor or pharmacist before using other topical
acne medications at the same time or immediately
following use of this product. May increase dryness or
irritation of the skin. If this occurs, only one medication
should be used unless directed by a doctor.
When using this product apply to affected area only.
Do not use on broken skin or apply to large areas of the
body.
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
-Cleanse skin thoroughly before applying.
-Cover the entire affected area with a thin layer one to
three times daily. Because excessive drying of the skin
may occur, start with one application daily, then
gradually increase to two or three times daily if needed
or directed by a doctor. If bothersome dryness or
peeling occurs, reduce application to once a day or
every other day.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADVANCED ACNE SPOT TREATMENT
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58194-030 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 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) AMMONIA (UNII: 5138Q19F1X) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) LAURETH-7 (UNII: Z95S6G8201) METHYL LACTATE, (-)- (UNII: 0379G9C44S) PARAFFIN (UNII: I9O0E3H2ZE) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG) PURSLANE (UNII: M6S840WXG5) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58194-030-01 1 in 1 CARTON 1 21 g in 1 TUBE; 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 01/11/2016 Labeler - Shanghai Weierya Daily Chemicals Factory (420359333) Establishment Name Address ID/FEI Business Operations Shanghai Weierya Daily Chemicals Factory 420359333 manufacture(58194-030)
