Label: DERMAHARMONY SULFUR AND SALICYLIC ACID- salicylic acid, sulfur liquid
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NDC Code(s):
71819-006-04,
71819-006-10,
71819-006-12,
71819-006-64, view more71819-006-99
- Packager: D3 Development, Inc.
- 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 March 26, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMAHARMONY SULFUR AND SALICYLIC ACID
salicylic acid, sulfur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71819-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 5 g in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) PUMICE (UNII: NT5NN5KL16) WATER (UNII: 059QF0KO0R) POTASSIUM COCOATE (UNII: F8U72V8ZXP) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM OLIVATE (UNII: 3H8EO46QKE) POTASSIUM OLEATE (UNII: 74WHF607EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71819-006-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2020 2 NDC:71819-006-10 296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2020 3 NDC:71819-006-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2020 4 NDC:71819-006-64 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2020 5 NDC:71819-006-99 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 03/27/2020 Labeler - D3 Development, Inc. (043195877)