Label: ACNE FORMULA cream
- NDC Code(s): 83325-004-01
- Packager: Volans Epic LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients Purpose
- Use
- Warnings
- When using this product
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- Other lnformation
-
Inactive Ingredients
Purified Water, Dipropylene Glycol, Sodium Acrylates Copolymer and Lecithin, PEG-100 Stearate and Glyceryl Stearate, Purified Talc, Hydroxypropyl Starch Phosphate, Isododecane, C13-15 Alkane, Titanium Dioxide, Phenoxyethanol, Sodium Hydroxide, Hydroxyethyl cellulose, Citric Acid Monohydrate, Fragrance, Tetra Sodium EDTA
- Questions or Comments?
-
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:
Volans Epic LLC
Corporation Trust Center, 1209 Orange Street, Wilmington,
Delaware 19801, Country of New CastleMANUFACTURED BY:
Pontika Aerotech Limited
Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District
Sirmour, Himachal Pradesh-173001, IndiaMfg.Lic.No.:N-COS/18/47
Made in India
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ACNE FORMULA
acne formula creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83325-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.5 g in 50 g HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM 0.05 g in 50 g NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 50 g ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 0.5 g in 50 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.03 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM ACRYLATE (UNII: 7C98FKB43H) GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947) TALC (UNII: 7SEV7J4R1U) HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A) ISODODECANE (UNII: A8289P68Y2) C13-15 ALKANE (UNII: 114P5I43UJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FRAGRANCE 13576 (UNII: 5EM498GW35) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83325-004-01 50 g in 1 BOTTLE; Type 0: Not a Combination Product 02/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 02/02/2024 Labeler - Volans Epic LLC (118944905) Establishment Name Address ID/FEI Business Operations PONTIKA AEROTECH LIMITED 861299010 manufacture(83325-004) , analysis(83325-004)
