SOFT AND SILKY/HEALTH GUARD ANTIBACTERIAL HAND- antibacterial hand soap liquid 
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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Soft & Silky/Health Guard Antibacterial Hand

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

Water, Ammounium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Hydroxysultaine, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Fragrance, Citric Acid, Tetrasodium EDTA, DMDM Hydantoin, Yellow 5, Red 33.

50865-050-12/65/90: Handwash to help decrease bacteria on the skin.

50865-050-19/67/82/93: For handwashing to decrease bacteria on skin.

50865-050-09/12/65/82:

For external use only.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

50865-050-19/67/93:

For external use only.

Do not use in the eyes.

Discontinue/Stop use if, in rare instances, irritation and redness 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.

50865-050-09/12/65:

  • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
  • Children under six years of age should be supervised when using this product.

50865-050-82/93:

To decrease bacteria on skin, apply a small amount, covering hands with product for 30 seconds. Add water, later and rinse.

50865-050-67: Wet hands, apply a small amount of product and work into a lather for 20 seconds, rinse thoroughly, dry hands completely.

50865-050-19: Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

A handwash to decrease bacteria on the skin.

Do not use in the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

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

50865-050-82.jpg 50865-050-82.jpg

50865-050-12.jpg  50865-050-12.jpg

SOFT AND SILKY/HEALTH GUARD ANTIBACTERIAL HAND 
antibacterial hand soap liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-050
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
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE SODIUM (UNII: MP1J8420LU)  
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
ISOSTEARAMIDOPROPYL MORPHOLINE LACTATE (UNII: 082Y3WQI5K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50865-050-65800 mL in 1 BAG; Type 0: Not a Combination Product09/20/2013
2NDC:50865-050-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/20/2013
3NDC:50865-050-19237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/20/2013
4NDC:50865-050-672000 mL in 1 BAG; Type 0: Not a Combination Product09/20/2013
5NDC:50865-050-82800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/20/2013
6NDC:50865-050-931200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/20/2013
7NDC:50865-050-121200 mL in 1 BAG; Type 0: Not a Combination Product09/20/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/20/201310/10/2017
Labeler - Kutol Products Company, Inc. (004236139)
Registrant - Kutol Products Company, Inc. (004236139)
Establishment
NameAddressID/FEIBusiness Operations
Kutol Products Company, Inc.004236139manufacture(50865-050)

Revised: 2/2022
 
Kutol Products Company, Inc.