Foaming Instant Hand Sanitizer

Foaming Instant Hand Sanitizer by

Drug Labeling and Warnings

Foaming Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by RJ Schinner, Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FOAMING INSTANT HAND SANITIZER- foaming instant hand sanitizer solution 
RJ Schinner

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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Foaming Instant Hand Sanitizer

Benzethonium Chloride 0.2% w/w.....Antibacterial Agent

Water, Fragrance, Aloe Barbadensis Leaf, Tocopheryl Acetate, Cocamidopropyl Betaine, Propylene Glycol, Phenoxyethanol, PEG-7 Glyceryl Cocoate, Tetrasodium EDTA.

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

For external use only.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

To decrease bacteria on skin, apply small amount to palm. Briskly rub, covering hands with product until dry.

Hand sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Avoid contact with eyes. If contact occurs, flush with water.

Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

FOAMING INSTANT HAND SANITIZER 
foaming instant hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	7.56 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EDETATE SODIUM (UNII: MP1J8420LU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-000-01	208175 mL in 1 DRUM; Type 0: Not a Combination Product	03/07/2017	01/27/2020
2	NDC: 71303-000-02	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017	01/27/2020
3	NDC: 71303-000-03	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017	01/27/2020
4	NDC: 71303-000-04	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/07/2017	01/27/2020
5	NDC: 71303-000-05	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/07/2017	01/27/2020
6	NDC: 71303-000-06	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/07/2017	01/27/2020
7	NDC: 71303-000-07	950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017	01/27/2020
8	NDC: 71303-000-08	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2017	01/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/07/2017	01/27/2020

Labeler - RJ Schinner (023432909)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	analysis(71303-000) , sterilize(71303-000) , manufacture(71303-000) , pack(71303-000)

Revised: 1/2020

Document Id: 9d2532a4-9397-0612-e053-2a95a90a0711

34390-5

Set id: 49988a01-c095-0020-e054-00144ff8d46c

Version: 3

Effective Time: 20200127