HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Punch Studio, LLC, Ningbo Pretty Tourism Manufacture Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

EHTANOL 62%. PURPOSE: ANTISEPTIC

PURPOSE

ANTISEPTIC

USES

• TO HELP REDUCE BACTERIA ON HANDS
• WHEN WATER & SOAP ARE NOT AVAILABLE

WARNINGS

• FOR EXTERNAL USE ONLY
• KEEP OUT OF EYES
• FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME

DO NOT USE

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

KEEP OUT OF REACK OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CALL A POISON CONTROL VENTER RIGHT AWAY.

DIRECTIONS

• APPLY AS NEEDED INTO PALM OF HANDS, RUB HANDS TOGETHER UNTIL DRY
• SUPERVISE CHILDREN UNDER 6 YEARS OLD

INACTIVE INGREDIENTS

WATER, TRIETHANOLAMINE, CARBOMER, GLYCERIN, PROPYLENE GLYCOL, ALOE BARBADENSIS EXTRACT, TOCOPHERYL ACETATE

Package Label - Principal Display Panel

150 mL NDC: 75601-0001-1

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75601-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	93 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	55.707 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.0015 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0015 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.15 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.42 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.42 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75601-0001-1	150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

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

Labeler - Punch Studio, LLC (843912440)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pretty Tourism Manufacture Co., Ltd.		553193489	manufacture(75601-0001)

Establishment
Name	Address	ID/FEI	Business Operations
Punch Studio, LLC		843912440	relabel(75601-0001)