3 in 1 Antibacterial Hair and Body Wash

3 in 1 Antibacterial Hair and Body Wash by

Drug Labeling and Warnings

3 in 1 Antibacterial Hair and Body Wash by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

50865-076-41.jpg 50865-076-41.jpg

3 IN 1 ANTIBACTERIAL HAIR AND BODY WASH 
3 in 1 antibacterial hair and body wash solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50865-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN11.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50865-076-073785 mL in 1 JUG; Type 0: Not a Combination Product11/06/2013
2NDC: 50865-076-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/06/2013
3NDC: 50865-076-361000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/06/2013
4NDC: 50865-076-411000 mL in 1 BAG; Type 0: Not a Combination Product11/06/2013
5NDC: 50865-076-672000 mL in 1 BAG; Type 0: Not a Combination Product11/06/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/06/201310/03/2017
Labeler - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-076) , analysis(50865-076) , label(50865-076) , pack(50865-076)

Revised: 11/2019
 
Kutol Products Company, Inc.