Label: SKININC- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80761-001-01 - Packager: Skininc Global Pte. Ltd.
- 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 October 7, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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Warnings
- Flammable. Keep away from fire or flame.
- For external use only.
- When using this product do not use it in or near eyes. In case of contact, rinse eyes thoroughly with water.
- Stop use and ask a doctor if irritation or rash appears and lasts.
- Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
- Uses
- Directions
- KEEP OUT OF REACH OF CHILDREN
- Other Information
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Inactive Ingredient
Water,Mannitol,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Aminomethyl Propanol,Microcrystalline Cellulose,PEG-20 Sorbitan Cocoate,Carbomer,Disodium EDTA,Butylene Glycol,1,2-Hexanediol,Mentha Rotundifolia Leaf Extract,Mentha Piperita (Peppermint) Leaf Extract,Mentha Aquatica Leaf Extract,Cucurbita Pepo (Pumpkin) Fruit Extract,Perilla Frutescens Extract,Rheum Palmatum Root Extract,Angelica Gigas Extract,Cnidium Officinale Root Extract,Melaleuca Alternifolia (Tea Tree) Leaf Extract, Fragrance
- Product Image
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INGREDIENTS AND APPEARANCE
SKININC
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80761-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 65 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MANNITOL (UNII: 3OWL53L36A) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MENTHA X ROTUNDIFOLIA LEAF (UNII: K59TXG2L3U) MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) MENTHA AQUATICA LEAF (UNII: 5M106ME6PT) PUMPKIN (UNII: SYW0QUB89Y) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80761-001-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/07/2020 Labeler - Skininc Global Pte. Ltd. (595292498)