Hand Sanitizer by Raining Rose, INC / Raining Rose HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Raining Rose, INC, Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethanol 70%

PURPOSE

Antimicrobial

INDICATIONS & USAGE

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

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

• Dispense an adequate amount in your palm to cover all surfaces of hands completely
• Rub hands together until dry
• Does not require rinsing.

OTHER SAFETY INFORMATION

• Do not store above 105*
• May discolor some fabrics

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product 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)