KLEENSWELL GEL HAND SANITIZER- alcohol gel

KleenSwell Gel Hand Sanitizer by

Drug Labeling and Warnings

KleenSwell Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hygienic Labs, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

KLEENSWELL GEL HAND SANITIZER - 70% alcohol gel
Hygienic Labs, 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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This is hand sanitizer is manufactured using United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).

Active Ingredients

Medicinal ingredient: Ethyl alcohol 70% v/v............... Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce viruses and bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Water (Aqua), Glycerin, Hydrogen Peroxide, Alkyl Acrylate Crosspolymer, Triethanolamine, Aloe, Lauryl Alcohol, Myristyl Alcohol, Fragrance (Parfum), PEG Dimethicone

Package Label - Principal Product Label

3800 mL NDC: 79692-003-01

19000 mL NDC: 79692-003-05

189000 mL NDC: 79692-003-50

250 mL NDC: 79692-003-08

500 mL NDC: 79692-003-16

INGREDIENTS AND APPEARANCE

KLEENSWELL GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79692-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70.6586 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.6023 mL  in 100 mL
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)	0.0187 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.2665 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.1258 mL  in 100 mL
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	7.6152 mL  in 100 mL
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)	0.0216 mL  in 100 mL
MYRISTYL LACTATE (UNII: 1D822OC34X)	0.2656 mL  in 100 mL
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	1.3344 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79692-003-01	3800 mL in 1 JUG; Type 0: Not a Combination Product	08/15/2020
2	NDC: 79692-003-50	189000 mL in 1 DRUM; Type 0: Not a Combination Product	08/15/2020
3	NDC: 79692-003-05	19000 mL in 1 PAIL; Type 0: Not a Combination Product	08/15/2020
4	NDC: 79692-003-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020
5	NDC: 79692-003-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/15/2020

Labeler - Hygienic Labs, LLC. (117590193)

Establishment
Name	Address	ID/FEI	Business Operations
Hygienic Labs, LLC.		117580036	label(79692-003) , repack(79692-003)

Establishment
Name	Address	ID/FEI	Business Operations
Hygienic Labs, LLC.		117590193	label(79692-003) , manufacture(79692-003)