Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79894-006-01 - Packager: SAMARA COSMETICS S.A.S.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Uses
- Active Ingredient
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Warnings
- For external use only-
- When using this product keep out o f eyes. In case of contact, flush with water several minutes.
- Keep out of reach of children except under adult supervision
- If swalow get medical help or contact a Poison Control Center right away.
- Flammable: Keep away from heat and flame.
- Stop use and ask Doctor: if skin irritation develops.
- Do not swalow
- Children under 6 years old should be supervised when using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
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Inactive Ingredients
Water Carbomer, Triethanolamine, Olea Europaea Fruit Oil, Panthenol, Glycerin, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower/Leaf Extract, Rosmarinus Officinalis Leaf Extract, Thymus Vulgaris Leaf Oil, Linum Usitatissimum Seed Oil, Tocopheryl acetate (Vitamina E), Hydroxypropyl methylcellulose, Ethyl Lauroyl Arginate, Propylene Glycol, Fragrance, Phenoxyethanol, Ethylhexylglycerin, Citric Acid
- Questions?
- Uses
- Hand Sanitizer
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79894-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 68 mL in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL in 100 mL OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) 0.01 mL in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.3 mL in 100 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL in 100 mL CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) 0.3 mL in 100 mL THYMUS VULGARIS LEAF (UNII: GRX3499643) 0.1 mL in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 mL in 100 mL HYPROMELLOSES (UNII: 3NXW29V3WO) 0.1 mL in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 0.2 mL in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.72 mL in 100 mL FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF) 0.3 mL in 100 mL ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O) 0.3 mL in 100 mL LINUM USITATISSIMUM WHOLE (UNII: 310OJT00CG) 0.1 mL in 100 mL ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB) 0.1 mL in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.07 mL in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 mL in 100 mL WATER (UNII: 059QF0KO0R) 29.79 mL in 100 mL POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 0.1 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL CAMELLIA OIL (UNII: T1PE06G0VE) 0.3 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79894-006-01 500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/29/2020 Labeler - SAMARA COSMETICS S.A.S. (881793172) Registrant - SAMARA COSMETICS S.A.S. (881793172) Establishment Name Address ID/FEI Business Operations SAMARA COSMETICS S.A.S. 881793172 manufacture(79894-006)
