3 IN 1 ANTIBACTERIAL HAIR AND BODY WASH- 3 in 1 antibacterial hair and body wash solution
Kutol Products Company, 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.

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3 in 1 Antibacterial Hair and Body Wash

Triclosan 0.3% w/w.....Antibacterial Agent

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Hydroxysultaine, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Fragrance, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin, Blue 1.

For handwashing to help reduce bacteria on the skin

For external use only.

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

Apply to hair or body. Work into a rich lather. Massage hair and body completely for at least 30 seconds. Rinse thoroughly. Dry completely.

For handwashing to help reduce bacteria on the skin.

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

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3 IN 1 ANTIBACTERIAL HAIR AND BODY WASH
3 in 1 antibacterial hair and body wash solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50865-076
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	11.7 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50865-076-07	3785 mL in 1 JUG; Type 0: Not a Combination Product	11/06/2013	10/03/2017
2	NDC:50865-076-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/06/2013	10/03/2017
3	NDC:50865-076-36	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/06/2013	10/03/2017
4	NDC:50865-076-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	11/06/2013	10/03/2017
5	NDC:50865-076-67	2000 mL in 1 BAG; Type 0: Not a Combination Product	11/06/2013	10/03/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/06/2013	10/03/2017

Labeler - Kutol Products Company, Inc. (004236139)

Name	Address	ID/FEI	Business Operations
Establishment
Kutol Products Company, Inc.		004236139	manufacture(50865-076) , analysis(50865-076) , label(50865-076) , pack(50865-076)

Revised: 10/2021

Document Id: cddb69d2-35a3-55e2-e053-2a95a90a6438

Set id: fcb09709-ca93-4465-a188-09dd03910424

Version: 7

Effective Time: 20211008

Kutol Products Company, Inc.