Label: 2% SALICYLIC ACID FACIAL CLEANSER- glycerin, kaolin clay, salicylic acid, zinc pca, azelaic acid liquid
- NDC Code(s): 83325-003-01
- Packager: Volans Epic 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.
Drug Label Information
Updated April 11, 2023
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- Official Label (Printer Friendly)
- PURPOSE
-
Drug Facts
Active ingdredient Purpose
Glycerin 5.0% .............................................................Adds Hydration
Kaolin clay 2.0% ..............................................................Absorbs Oil
Salicylic acid 2.0% ...........................................................Treats Acne
Zinc PCA 1.0% ..........................................Reduces Redness On Skin
Azelaic acid 1.0% ..........................................Reduces Spots On Skin
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- DOSAGE & ADMINISTRATION
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Questions or Comments?
For any queries please contact us at info@majesticpure.com or call us at +1530- 464-6426.
Distributed By & Domestic Representative Address:
Volans Epic LLC
Corporation Trust Centre, 1209 Orange Street, Wilmington,
Delaware 19801, County of New CastleManufactured By:
HCP Wellness Pvt. Ltd.
Plot No:08, Ozone Industrial Park,
Bavia-Bagodara Highway, Bhayla, Ahmedabad-382220.Mfg. LIC. NO. : GC/1348
Product of India
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
2% SALICYLIC ACID FACIAL CLEANSER
glycerin, kaolin clay, salicylic acid, zinc pca, azelaic acid liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83325-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 50 mg in 236 mL KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) KAOLIN 20 mg in 236 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 20 mg in 236 mL ZINC PIDOLATE (UNII: C32PQ86DH4) (ZINC PIDOLATE - UNII:C32PQ86DH4) ZINC PIDOLATE 10 mg in 236 mL AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 10 mg in 236 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETIC ACID (UNII: 9G34HU7RV0) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DMDM HYDANTOIN (UNII: BYR0546TOW) PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U) LUVISET 360 (UNII: 05BG6GY6YK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83325-003-01 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 04/06/2023 Labeler - Volans Epic LLC (118944905) Registrant - MENSA BRAND TECHNOLOGIES PRIVATE LIMITED (854380965) Establishment Name Address ID/FEI Business Operations HCP Wellness Pvt. Ltd 854270676 manufacture(83325-003) , label(83325-003) , pack(83325-003)
