018 Skintegrity Antibacterial Hand Soap (amber)

Skintegrity Antibacterial Hand by

Drug Labeling and Warnings

Skintegrity Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKINTEGRITY ANTIBACTERIAL HAND AMBER- triclosan soap 
Medline Industries, 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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018 Skintegrity Antibacterial Hand Soap (amber)

Active ingredient

Triclosan 0.5%

Purpose

Antiseptic Handwash

Uses

  • for handwashing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

  • avoid contact with eyes. In case of eye contact, immediately flush with water.

Stop use and ask a doctor if

  • irritation or redness develop
  • condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • pump into wet hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium Chloride, Cocamide DEA, Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7, DMDM Hydantoin, BHT, Fragrance, Citric Acid, Tetrasodium EDTA, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Citric Acid, Yellow 5, Red 33.

Package/Label Principal Display Panel

Skintegrity Antibacterial hand soap principal display panel

MEDLINE

NDC: 53329-018-04

skintegrity

antibacterial hand soap

4 fl oz (118 mL)

SKINTEGRITY ANTIBACTERIAL HAND  AMBER
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53329-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLUTAMIC ACID (UNII: 3KX376GY7L)  
LEUCINE (UNII: GMW67QNF9C)  
SERINE (UNII: 452VLY9402)  
PHENYLALANINE (UNII: 47E5O17Y3R)  
PROLINE (UNII: 9DLQ4CIU6V)  
GLYCINE (UNII: TE7660XO1C)  
VALINE (UNII: HG18B9YRS7)  
ISOLEUCINE (UNII: 04Y7590D77)  
ARGININE (UNII: 94ZLA3W45F)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53329-018-201 in 1 BOX04/08/201103/01/2018
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC: 53329-018-841 in 1 BOX04/08/201103/01/2018
21000 mL in 1 BAG; Type 0: Not a Combination Product
3NDC: 53329-018-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/201103/01/2018
4NDC: 53329-018-08221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/08/201103/01/2018
5NDC: 53329-018-06473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/08/201103/01/2018
6NDC: 53329-018-253785 mL in 1 JUG; Type 0: Not a Combination Product04/08/201103/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/08/201103/01/2018
Labeler - Medline Industries, Inc. (025460908)
Establishment
NameAddressID/FEIBusiness Operations
KUTOL PRODUCTS COMPANY004236139manufacture(53329-018)

Revised: 12/2019
 
Medline Industries, Inc.