CHOICE WELLNESS HAND SANITIZER GEL- benzalkonium chloride gel
Enviro Specialty Chemicals 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.

----------

HAND SANITIZER GEL

DRUG FACTS

ACTIVE INGREDIENT:

BENZALKONIUM CHLORIDE 0.13%

PURPOSE: ANTISEPTIC/HAND & SKIN SANITIZER

USES: HAND SANITIZER TO HELP DECREASE BACTERIA ON THE SKIN.

RECOMMENDED FOR REPEATED USE.

DIRECTIONS: APPLY LIBERALLY TO THE PALMS OF THE HANDS.

RUB INTO THE SKIN UNTIL DRY.

WARNINGS:

- DO NOT FREEZE. FOR EXTERNAL USE ONLY. DO NOT USE IN EARS, EYES OR MOUTH. IN CASE OF CONTACT WITH EYES,

FLUSH EYES WITH WATER.

- STOP USE AND SEEK MEDICAL ADVICE IF REDNESS OR IRRITATION DEVELOP AND PERSIST FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN. CHILDREN UNDER 6 YEARS OF AGE MUST BE SUPERVISED

WHEN USING THIS PRODUCT.

STORE IN A COOL PLACE BELOW 104Fº (40Cº)

INACTIVE INGREDIENTS:

ALOE BARBADENSIS LEAF EXTRACT, AQUA, CITRIC ACID CAPRYLYL GLUCOSIDE, HYDROXYETHYL CELLULOSE,

POLYHEXANIDE, PHENOXYETHANOL TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE.

ALL DAY PROTECTION

WITH ONE APPLICATION

LONG LASTING ALCOHOL-FREE PROTECTION

FDA REGISTERED

MADE IN USA

KILLS 99.99% OF GERMS

SOFTENS & CONDITIONS

FAST ACTING 15 SECOND FORMULA

WITH SOOTHING ALOE VERA

Formulated and enhanced with Zetrisil

SAFE FOR KIDS & INFANTS

DISTRIBUTED BY:

CHOICE WELLNESS, INC.

201 5TH ST (STE 1200)

SHERIDAN, WYOMING, 82001

www.choicewellnessbrands.com

PLEASE DISPOSE OF PACKAGING THOUGHTFULLY.

MANUFACTURED IN THE USA

Packaging

CHOICE WELLNESS HAND SANITIZER GEL
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71884-021
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
POLIHEXANIDE (UNII: 322U039GMF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYSILYLPROPYL STEARDIMONIUM CHLORIDE (UNII: XGN40YQC7B)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71884-021-02	59.14 mL in 1 TUBE; Type 0: Not a Combination Product	05/26/2020	12/09/2021
2	NDC:71884-021-08	236.6 mL in 1 TUBE; Type 0: Not a Combination Product	05/26/2020	12/09/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/26/2020	12/09/2021

Labeler - Enviro Specialty Chemicals Inc (202621850)

Revised: 12/2021

Document Id: b13162b0-474f-4028-94c4-6a9a27b583fb

Set id: 9f9d2211-0fe9-44c0-9b41-5f12ae4f9b87

Version: 2

Effective Time: 20211209

Enviro Specialty Chemicals Inc