Label: 3% OAT BODY WASH FOR SENSITIVE SKIN (glycerin, oatmeal extract, sodium pca, vitamin b5, hyaluronic acid, ceramide ng, rosa canina- rosehip seed oil liquid
- NDC Code(s): 83325-002-02
- Packager: Volans Epic LLC
- Category: HUMAN OTC DRUG LABEL
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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Drug Facts
Active Ingdredient Purpose
Glycerin 5.0%................................................................ Adds Hydration
Oatmeal Extract 3.0%...............................................Reduces Sensitivity
Sodium PCA 2.0%...................................................Adds Moisturisation
Vitamin B5 1.0%..............................................Reduce Facial Blemishes
Hyaluronic Acid 0.5%.................................................Reduces Wrinkles
Ceramide NG 0.1%...................................................Reduces Sensitivity
Rosa Canina (Rosehip) Seed oil 0.1%.............................Nourishes Skin - PURPOSE
- Use
- Warnings
- When using this product
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
- Inactive ingredients
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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-382220Mfg. LIC. NO. : GC/1348
Product of India
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INGREDIENTS AND APPEARANCE
3% OAT BODY WASH FOR SENSITIVE SKIN
glycerin, oatmeal extract, sodium pca, vitamin b5, hyaluronic acid, ceramide ng, rosa canina (rosehip) seed oil liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83325-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 50 mg in 472 mL OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 30 mg in 472 mL SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) (PYRROLIDONE CARBOXYLIC ACID - UNII:6VT1YZM21H) SODIUM PYRROLIDONE CARBOXYLATE 20 mg in 472 mL PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID 10 mg in 472 mL HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID 5 mg in 472 mL CERAMIDE NG (UNII: C04977SRJ5) (CERAMIDE NG - UNII:C04977SRJ5) CERAMIDE NG 1 mg in 472 mL ROSA CANINA SEED OIL (UNII: MHT97MG5P8) (ROSA CANINA SEED OIL - UNII:MHT97MG5P8) ROSA CANINA SEED OIL 1 mg in 472 mL Inactive Ingredients Ingredient Name Strength PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U) SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) DMDM HYDANTOIN (UNII: BYR0546TOW) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) LUVISET 360 (UNII: 05BG6GY6YK) DEXPANTHENOL (UNII: 1O6C93RI7Z) WATER (UNII: 059QF0KO0R) EDETIC ACID (UNII: 9G34HU7RV0) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83325-002-02 472 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 PRIVATE LIMITED 854270676 manufacture(83325-002) , label(83325-002) , pack(83325-002)