Label: HAND SANITIZER gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 65692-2063-1 - Packager: Raining Rose, INC
- 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 February 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Flammable, keep away from fire or flame. For external use only. Do not use in eyes. In case of eye contact flush thoroughly with water and seek medical attention. Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-2063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) AMINOMETHYLPROPANOL (PERFLUORO-C6-C12 ETHYL)PHOSPHATE (UNII: QCD5R22RNT) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-2063-1 44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/01/2021 Labeler - Raining Rose, INC (083819404) Registrant - Raining Rose, INC (083819404) Establishment Name Address ID/FEI Business Operations Raining Rose 083819404 pack(65692-2063) , label(65692-2063)