Wash-free Hand Sanitizer Gel: Package Insert and Label Information

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.

ACTIVE INGREDIENTS

Alcohol 75%

Purpose

Killing microorganism like colibacillus, staphylococcus aureus,candida albicans,

pseudomonas aerugino.

Uses

Uses Hand Sanitizer to help reduce bacteria on skin

Warnings

This product is sterilized for external use.
Do not take it orally.
Keep out of reach of children and Allergies are disabled.
When using, do not contact with eyes, rinse with water immediately and consult a doctor in case of contract.

Do not take it orally.

When using, do not contact with eyes, rinse with water immediately and consult a doctor in case of contract.

/

Keep out of reach of children and Allergies are disabled.

Directions

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

completely dry.

Other information

Keep away from fire
Place in a cool and dry place

Inactive ingredients

Water, Carbomer, Glycerin, Aminomethyl Propanol

Package Label — Principal Display Panel

150
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3785
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250
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WASH-FREE HAND SANITIZER GEL
wash-free hand sanitizer gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75132-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75132-011-01 150 mL in 1 BOTTLE None
2 NDC:75132-011-02 250 mL in 1 BOTTLE None
3 NDC:75132-011-03 3785 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/12/2020
Labeler — Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
Registrant — Guangdong Kemei Pharmaceutical Technology Co., Ltd. (554528507)
Establishment
Name Address ID/FEI Operations
Guangdong Kemei Pharmaceutical Technology Co., Ltd. 554528507 manufacture (75132-011)

Revised: 05/2020 Guangdong Kemei Pharmaceutical Technology Co., Ltd.

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