KENTEX INSTANT HAND SANITIZER WITH ALOE VERA- alcohol solution
Kentron Healthcare, Inc.

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 70% v/v

Purpose

Antimicrobial

Use

Decrease bacteria on hands

Warnings

For external use only

Flammable. Keep away from fire or flame

keep out of eyes. In case of eye contact, immediately flush with water and get medical help

Keep out of reach of children. If swallowed, get medical help or contact a poison control immediately

Directions

Squeeze on hands. Rub hands together until dry

Inactive ingredients

Water, Carbomer, Triethanolamine, Glycerin, Aloe Vera Gel, Propylene Glycol, Vitamin E

image description

KENTEX INSTANT HAND SANITIZER WITH ALOE VERA
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69556-333
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69556-333-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
2	NDC:69556-333-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
3	NDC:69556-333-32	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020
4	NDC:69556-333-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/27/2020

Labeler - Kentron Healthcare, Inc. (618825723)

Name	Address	ID/FEI	Business Operations
Establishment
JIANGSU HANHE DAILY CHEMICALS CO., LTD.		414409758	manufacture(69556-333)