Soft & Silky/Health Guard Antibacterial Hand

Soft and Silky/Health Guard Antibacterial Hand by

Drug Labeling and Warnings

Soft and Silky/Health Guard Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

----------

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

  50865-050-12.jpg

SOFT AND SILKY/HEALTH GUARD ANTIBACTERIAL HAND 
antibacterial hand soap liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-050
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-050-65	800 mL in 1 BAG; Type 0: Not a Combination Product	09/20/2013
2	NDC: 50865-050-09	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/2013
3	NDC: 50865-050-19	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/2013
4	NDC: 50865-050-67	2000 mL in 1 BAG; Type 0: Not a Combination Product	09/20/2013
5	NDC: 50865-050-82	800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/2013
6	NDC: 50865-050-93	1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/20/2013
7	NDC: 50865-050-12	1200 mL in 1 BAG; Type 0: Not a Combination Product	09/20/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/20/2013	10/10/2017

Labeler - Kutol Products Company, Inc. (004236139)

Registrant - Kutol Products Company, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-050) , pack(50865-050) , label(50865-050) , analysis(50865-050)

Revised: 11/2019

Document Id: 9768f95d-d472-cf17-e053-2995a90a10f8

34390-5

Set id: 8fd8b4bc-d8a9-4ab2-93a4-e4ad82101b3e

Version: 4

Effective Time: 20191115