Label: 111MEDCO 2% SALICYLIC ACID CLEANSING BAR- salicylic acid soap
- NDC Code(s): 72811-000-04
- Packager: 111MedCo 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.
Updated October 17, 2022
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- Drug Facts
- Active ingredient
For external use only
When using this product
skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a healthcare provider.
- Apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne, avoiding contact with eye Rinse thoroughly and pat dry with a clean towel
- Because bothersome dryness of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed
- If bothersome drying or peeling occurs, reduce application to once a day or every other day
- Inactive ingredients
- Package Labeling: 111MedCo 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811-000-04)
INGREDIENTS AND APPEARANCE
111MEDCO 2% SALICYLIC ACID CLEANSING BAR
salicylic acid soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72811-000 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 in 1 g Inactive Ingredients Ingredient Name Strength SODIUM PALMATE (UNII: S0A6004K3Z) SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72811-000-04 113 g in 1 CARTON; Type 0: Not a Combination Product 07/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 07/01/2022 Labeler - 111MedCo LLC (065115643)