Label: OXY CLEANSING PADS DAILY DEFENSE- salicylic acid swab
- NDC Code(s): 10742-3204-1, 10742-3204-2, 10742-3204-3, 10742-3204-4
- Packager: The Mentholatum Company
- 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 7, 2023
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- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water.
- 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.
- do not leave pad on skin
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Directions
- use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily
- because too much drying of the skin may occur, start with 1 application, then gradually increase to 2 or 3 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
- Sensitivity test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow direction above.
Other information
- KEEP TIGHTLY CLOSED
- avoid storing at temperatures above 100˚F (38˚C)
- protect from freezing
- keep away from flame, fire and heat
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
OXY CLEANSING PADS DAILY DEFENSE
salicylic acid swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-3204 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOCETETH-20 (UNII: O020065R7Z) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) WATER (UNII: 059QF0KO0R) EDETATE TRISODIUM (UNII: 420IP921MB) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-3204-1 90 in 1 JAR; Type 0: Not a Combination Product 08/01/2016 2 NDC:10742-3204-2 55 in 1 JAR; Type 0: Not a Combination Product 08/01/2016 3 NDC:10742-3204-3 115 in 1 JAR; Type 0: Not a Combination Product 08/01/2016 4 NDC:10742-3204-4 70 in 1 JAR; Type 0: Not a Combination Product 08/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 08/01/2016 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-3204)
