Skintegrity antibacterial handfoaming with skin conditioners soap

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

  • apply a small amount, covering hands with product for 30 seconds.
  • add water, lather and rinse.

Inactive ingredients

Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate,PEG-80 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Cocamide MEA, Propylene Glycol, Fragrance, Citric Acid, Glutamic Acid, Leucine, Serine, Phenylalanine, Proline, Glycine, Valine, Isoleucine, Arginine, Quaternium-15, Tetrasodium EDTA, Aloe Barbadensis Leaf, Tocopheryl Acetate, Dimethicone, Red 33.

Ingredients and appearance - Product information

Skintegrity antibacterial handfoaming with skin conditioners soap- Triclosan

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 53329-977
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Triclosan ( UNII: 4NM5039Y5X)( Triclosan - UNII: 4NM5039Y5X ) 5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Ammonium lauryl sulfate ( UNII: Q7AO2R1M0B)
Sodium laureth sulfate ( UNII: BPV390UAP0)
Polyethylene glycol 4000 ( UNII: 4R4HFI6D95)
Glyceryl cocoate ( UNII: WVK1CT5994)
Coco monoethanolamide ( UNII: C80684146D)
Propylene glycol ( UNII: 6DC9Q167V3)
Citric acid monohydrate ( UNII: 2968PHW8QP)
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)
Quaternium-15 ( UNII: E40U03LEM0)
Edetate sodium ( UNII: MP1J8420LU)
Aloe vera leaf ( UNII: ZY81Z83H0X)
.alpha.-tocopherol acetate, d- ( UNII: A7E6112E4N)
Dimethicone ( UNII: 92RU3N3Y1O)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Disodium cocoamphodiacetate ( UNII: 18L9G3U51M)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 53329-977-84 1000mL in 1 BAG 2011/04/08
2 NDC: 53329-977-23 950mL in 1 BOTTLE, PUMP 2011/04/08

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333E USA 2011/04/08

Labeler - Medline Industries, Inc.( 025460908)

Establishment

Name ID/FEI Business Operations
Medline Industries, Inc. 025460908 manufacture( 53329-977)

Package label - principal display panel

NDC 53329-977-84

Skintegrity

foaming antibacterial hand soap

with emollients & skin conditioners

33.8 fl oz (1000 mL)