Label: 5% OAT FACIAL CLEANSER- glycerin, oatmeal extract,ceramide ng liquid
- NDC Code(s): 83325-005-03
- 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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- PURPOSE
- Drug Facts
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- Warnings
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- Other information
- Inactive Ingredients
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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/1348Product of India
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
5% OAT FACIAL CLEANSER
glycerin, oatmeal extract,ceramide ng liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83325-005 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 OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 50 mg in 236 mL CERAMIDE NG (UNII: C04977SRJ5) (CERAMIDE NG - UNII:C04977SRJ5) CERAMIDE NG 1 mg in 236 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) EDETIC ACID (UNII: 9G34HU7RV0) LUVISET 360 (UNII: 05BG6GY6YK) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO DIETHANOLAMIDE (UNII: 92005F972D) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U) DMDM HYDANTOIN (UNII: BYR0546TOW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83325-005-03 236 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 label(83325-005) , manufacture(83325-005) , pack(83325-005)