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

Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use.

Warnings• For external use only
• Flammable, keep away from fire or flame
• 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.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
• Dispense an adequate amount in your palm to cover all surfaces of hands completely.

• Rub hands together until dry. • Does not require rinsing.

Other Information
• Do not store above 105°F.
• May discolor some fabrics.

Inactive Ingredients: Water (Aqua), Isopropyl Alcohol, Orange Oil, Acrylates/C10-30 Akyl Acrylate Crosspolymer, Glycerin, Aloe Barbadensis Leaf Juice, Panthenol, Aminomethyl Propanol.

C10932 C10932B-01

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-2059
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
ORANGE OIL (UNII: AKN3KSD11B)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCITRUSImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-2059-144 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/30/2020
Labeler - Raining Rose, Inc (083819404)
Registrant - Raining Rose, Inc (083819404)
Establishment
NameAddressID/FEIBusiness Operations
Aire-Master America, Inc.057897381manufacture(65692-2059)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose, Inc083819404label(65692-2059) , pack(65692-2059)

Revised: 7/2020
Document Id: ab968dbf-e14b-591f-e053-2a95a90afee5
Set id: ab968d97-f38d-4ae0-e053-2a95a90ad62d
Version: 1
Effective Time: 20200729
 
Raining Rose, Inc