UNISENS - HAND SANITIZING WIPES - 70% ALCOHOL (79025-101), DELIST

HAND SANITIZING WIPES by

Drug Labeling and Warnings

HAND SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by UNISENS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZING WIPES 70 PERCENT- alcohol solution 
UNISENS LLC

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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UNISENS - HAND SANITIZING WIPES - 70% ALCOHOL (79025-101), DELIST

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

DO NOT USE

• ON CHILDREN LESS THAN 2 MONTHS OF AGE
• ON OPEN SKIN WOUNDS

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• WET HANDS THOROUGHLY WITH PRODUCT, RUB TOGETHER, AND ALLOW TO DRY WITHOUT WIPING OR RINSING.
• SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

ACTIVE INGREDIENTS

WATER, GLYCERIN, ALOE BARBADENSIS LEAF EXTRACT

HAND SANITIZING WIPES  70 PERCENT
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79025-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	7 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79025-101-11	20 in 1 POUCH; Type 0: Not a Combination Product	06/23/2020	12/31/2021
2	NDC: 79025-101-12	50 in 1 CONTAINER; Type 0: Not a Combination Product	06/23/2020	12/31/2021
3	NDC: 79025-101-13	100 in 1 CONTAINER; Type 0: Not a Combination Product	06/23/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2020	12/31/2021

Labeler - UNISENS LLC (117532521)

Revised: 1/2022

Document Id: d5a77d86-bef7-97f6-e053-2a95a90aaf14

34390-5

Set id: 0ffb614e-4f84-46c9-8127-4e0eb4ccd9f6

Version: 7

Effective Time: 20220115