Label: ACNE VANISHING GEL- 10% WITH SULFUR- benzoyl peroxide, sulfur gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70367-003-01, 70367-003-04 - Packager: Only Yourx, 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 January 23, 2020
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- WARNINGS
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients:
Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE VANISHING GEL- 10% WITH SULFUR
benzoyl peroxide, sulfur gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70367-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 10 g in 100 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 3 g in 100 mL Inactive Ingredients Ingredient Name Strength CETEARETH-22 (UNII: 28VZG1E234) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL OCTACOSANOATE (UNII: O7F4812VDX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) LAURETH-7 (UNII: Z95S6G8201) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461) DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) POLYSORBATE 20 (UNII: 7T1F30V5YH) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) GLYCERIN (UNII: PDC6A3C0OX) PEG-100 STEARATE (UNII: YD01N1999R) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70367-003-01 30 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 2 NDC:70367-003-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/26/2014 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/28/2014 Labeler - Only Yourx, Inc. (089207519)
