HAND SANITIZER- hand sanitizer gel 
Raining Rose, INC

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.

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Ethanol 70%

Antimicrobial

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

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.

Water (Aqua), Isopropyl Alcohol, Vanilla Fragrance, Acylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.

C10884 Combined-01

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-2063
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorVANILLAImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-2063-144 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2021
Labeler - Raining Rose, INC (083819404)
Registrant - Raining Rose, INC (083819404)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose083819404pack(65692-2063) , label(65692-2063)

Revised: 2/2021
Document Id: bc3fd1c9-0247-9e90-e053-2995a90a0176
Set id: bc3fd1c9-0246-9e90-e053-2995a90a0176
Version: 1
Effective Time: 20210226
 
Raining Rose, INC