Label: DERMESSE PAD TREATMENT 0.5- 0.5%salicylic acid lotion
DERMESSE PAD TREATMENT 2.0- 2%salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68723-400-05, 68723-401-20 - Packager: Axia Medical Solutions, LLC
- 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 11, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses:
- Warninigs:
- Ask a doctor or pharmacist before use if you are:
- Keep out of reach of children
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DIRECTIONS:
- Cleanse the skin thoroughly before applying medication
- 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.
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMESSE PAD TREATMENT 0.5
0.5%salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68723-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCOLIC ACID (UNII: 0WT12SX38S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68723-400-05 60 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2022 DERMESSE PAD TREATMENT 2.0
2%salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68723-401 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 Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCOLIC ACID (UNII: 0WT12SX38S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68723-401-20 60 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/01/2022 Labeler - Axia Medical Solutions, LLC (929224694) Registrant - Axia Medical Solutions, LLC (929224694) Establishment Name Address ID/FEI Business Operations Sanitor Corporation 797472792 manufacture(68723-400, 68723-401)