DURIDE HAND SANITIZER- alcohol gel
Rainbow International Services 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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Alcohol

Water(Aqua), Glycerin, Carbomer, Aloe Barbadensis Leaf Juice(Aloe Vera), Tocopheryl Acetate(Vitamin E), Phenoxyethanol, Aminomethyl propanol

Antimicrobial

■ Hand sanitizer to help reduce bacteria on the skin.

■ Flammable. Keep away from fire or flame.

■ For external use only.

■ in children less than 2 months of age
■ on open skin wounds

When using this product do not use in or near the 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 a Poison Control Center right away.

Store below 110℉(43℃)

Pump 1-2 times and rub it into your hand. For topical use only.

Duride Hand Sanitizer Label

DURIDE HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77498-210
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	210 mL in 300 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77498-210-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2020
2	NDC:77498-210-02	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2020
3	NDC:77498-210-03	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2020
4	NDC:77498-210-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/12/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/12/2020

Labeler - Rainbow International Services Inc. (046587936)

Registrant - Rainbow International Services Inc. (046587936)

Name	Address	ID/FEI	Business Operations
Establishment
Rainbow International Services Inc.		046587936	label(77498-210)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Pinshang Biotechnology Development Co.,Ltd		554530020	manufacture(77498-210)