WASH-FREE HAND SANITIZER GEL- alcohol gel 
Guangdong Kemei Pharmaceutical Technology 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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Wash-free Hand Sanitizer Gel

ACTIVE INGREDIENTS

Alcohol 75%

Purpose

Killing microorganism like colibacillus, staphylococcus aureus,candida albicans,

pseudomonas aerugino.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

This product is sterilized for external use.Do not take it orally.Allergies are

disabled.

When using, do not use in or near eyes.In case of contract,rinse with water immediately.Stop use

and consult a doctor in case of contract.Keep out of reach of children.

Directions

No water required.Apply 3ml amount to palm,rubbing in hands and fingers until

completely dry.

Other information

Keep away from fire and place in a cool and dry place.

Inactive ingredients

Water, Carbomer, Glycerin, Aminomethyl Propanol

Package Label - Principal Display Panel

15 ml label 30 ml label 50 ml label 60 ml label 80 ml label 100 ml label 120 ml label 236 ml label 300 ml label 500 ml label 1 L label 2 L label 5 L 反 label5 Ｌ正 label20 L 反 label20 Ｌ正 label50 Ｌ反 label50 L 正 label100 Ｌ反 label100 Ｌ正 label1000 L反 label1000 Ｌ正 label

WASH-FREE HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75132-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75132-001-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
2NDC:75132-001-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
3NDC:75132-001-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
4NDC:75132-001-0460 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
5NDC:75132-001-0580 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
6NDC:75132-001-06100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
7NDC:75132-001-07120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
8NDC:75132-001-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
9NDC:75132-001-09300 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
10NDC:75132-001-10500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
11NDC:75132-001-111000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
12NDC:75132-001-122000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
13NDC:75132-001-135000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
14NDC:75132-001-1420000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
15NDC:75132-001-1550000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
16NDC:75132-001-16100000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
17NDC:75132-001-171000000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/12/2020
Labeler - Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
Registrant - Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Kemei Pharmaceutical Technology Co., Ltd.554528507manufacture(75132-001)

Revised: 5/2020
Document Id: a648d9eb-29a1-73e6-e053-2a95a90af961
Set id: a3137e03-efe9-f0ad-e053-2995a90ac37b
Version: 3
Effective Time: 20200522
 
Guangdong Kemei Pharmaceutical Technology Co., Ltd.