AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ORIGINAL- alcohol solution
Zhejiang Aidi Cosmetics Co., Ltd

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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Active Ingredient(s)

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin

When water, soap, and towel are not available

Recommended for repeaded use

Warnings

For external use only.

Flammable. Keep away from fire or flame

Do not apply around eyes

Do not use in ears and mouth

When using this product avoid contact with eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours

Keep out of reach of children. Children must be supervised in use of this product.

Directions

Wet hands thoroughly with products and rub into skin until dry

Other information

Store at 20C (68-77F)

May discolor fabrics

Inactive ingredients

Water, triethanolamine, carbomer, aloe barbadensis gel, fragrance, glycerin, propylene glycol, tocopheryl acetate (Vitamin E)

image description

AMORAY PREMIUM INSTANT HAND SANITIZER WITH ALOE AND VITAMIN E ORIGINAL
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76114-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76114-005-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/23/2020

Labeler - Zhejiang Aidi Cosmetics Co., Ltd (530876820)

Registrant - Zhejiang Aidi Cosmetics Co., Ltd (530876820)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Aidi Cosmetics Co., Ltd		530876820	manufacture(76114-005)