HAND SANITIZER- hand sanitizer gel
Meixin Beauty & Health Care Products 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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003 Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antimicrobial

Warnings

Do not use

do not use in or near the eyes.

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 immediately.

Directions

Put enough product in your palm to cover hands and rubands together briskly until dry.
Children under 6 years of age should be supervised when using.

Other information

Store below 110°F(43°C)

Inactive ingredients

Water, Glycerin, Carbomer, Aloe Vera, Trithanolamine, Vitamine E

Hand sanitizer to help reduce bacteria on skin.

Package Label - Principal Display Panel

78565-003-08 30 ml 78565-003-08 30ml 78565-003-09 59 ml 78565-003-09 59ml 307 309 305 306 308 236 59 1 227 30 1 302 592 100ML 100

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78565-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78565-003-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78565-003-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78565-003-04	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:78565-003-05	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:78565-003-06	227 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:78565-003-07	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:78565-003-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:78565-003-08	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:78565-003-09	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)

Name	Address	ID/FEI	Business Operations
Establishment
Meixin Beauty & Health Care Products Co., Ltd.		421458605	manufacture(78565-003)