MIAOYUE INSTANT HAND SANITIZER- alcohol gel
Jiangsu Aimeili Cosmetic 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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Ethyl Alcohol 65% v/v

Purpose

Antiseptic

Use

To reduce bacteria on the skin that could cause disease

Recommended for repeated use

Use anywhere without water

Warnings

For external use only -hands

Flammable. Keep away from heat and flame

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

Discontinue if skin becomes irritated and ask a doctor

Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and rub until dry without wiping
For children under 6, use only under adult supervision
Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, aloe extract, triethanolamine, glycerol, carbomer

image description

MIAOYUE INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77573-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
ALOE (UNII: V5VD430YW9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77573-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
2	NDC:77573-001-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
3	NDC:77573-001-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
4	NDC:77573-001-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
5	NDC:77573-001-05	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
6	NDC:77573-001-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/14/2020

Labeler - Jiangsu Aimeili Cosmetic Co.,Ltd. (543903077)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Aimeili Cosmetic Co.,Ltd.		543903077	manufacture(77573-001)

Revised: 5/2020

Document Id: a5ef284a-adb0-9acc-e053-2995a90acbfe

Set id: 011a4af4-0de1-4cef-89d6-2817b98542f3

Version: 1

Effective Time: 20200518

Jiangsu Aimeili Cosmetic Co.,Ltd.