Label: DERMOSCRIBE SEBORRHEIC DERMATITIS- sulfur, salicylic acid, hydrocortisone cream
- NDC Code(s): 69683-202-11
- Packager: DERMOSCRIBE PTY LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 3, 2023
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- ACTIVE INGREDIENTS
- PURPOSE
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- DIRECTIONS
- INACTIVE INGREDIENTS
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INGREDIENTS AND APPEARANCE
DERMOSCRIBE SEBORRHEIC DERMATITIS
sulfur, salicylic acid, hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69683-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 g SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 3 g in 100 g HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) MINERAL OIL (UNII: T5L8T28FGP) GLYCOL STEARATE SE (UNII: 6YLY96TQL6) SORBITOL (UNII: 506T60A25R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERIN (UNII: PDC6A3C0OX) COCONUT OIL (UNII: Q9L0O73W7L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69683-202-11 60 g in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/23/2015 Labeler - DERMOSCRIBE PTY LTD (742164734)