Baza cleanse and protect cloth

Spl unclassified section

Drug Facts

Active ingredient

Dimethicone, 3%

Purpose

Skin Protectant

Uses

Temporarily protects the skin and helps relieve minor skin irritation due to incontinence-associated dermatitis. Helps seal out wetness.

Warnings

When using this product

  • avoid contact with eyes; not to be applied over deep or puncture wounds or lacerations
  • For external use only

Otc - keep out of reach of children section

  • Keep this and all drugs out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - ask doctor section

  • Consult a doctor: if condition worsens or does not improve within 7 days.

Directions

  • Remove the stool with underpad or Dimethicone cloth
  • Thoroughly cleanse the perineal area using a new Dimethicone cloth.
  • Dispose of soiled cloth in waste receptacle
  • Remove wet and soiled garments promptly; wipe affected area as often as necessary. Use a new Dimethicone cloth with each garment change.

Caution

  • Gloves diminish sensitivity to heat
  • Do not use excessively hot cloth
  • Closely monitor heat level with infants, unresponsive, and skin sensitive individuals.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Butylparaben, Citric Acid, Diazolidinyl Urea, Disodium Cocoamphodiacetate, Ethylparaben, Glycerin, Isobutylparaben, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Propylparaben, Tocopheryl Acetate, Water

Cloth material

Polyester rayon

Spl unclassified section

Distributed by: Coloplast Corp.
1601 W River Rd N, Minneapolis, MN 55411

Ingredients and appearance - Product information

Baza cleanse and protect cloth- Dimethicone

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11701-628
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Dimethicone ( UNII: 92RU3N3Y1O)( Dimethicone - UNII: 92RU3N3Y1O ) 3 gin 100 g

Inactive Ingredients

Ingredient Name Code
Aloe vera leaf ( UNII: ZY81Z83H0X)
Butylparaben ( UNII: 3QPI1U3FV8)
Citric acid monohydrate ( UNII: 2968PHW8QP)
Diazolidinyl urea ( UNII: H5RIZ3MPW4)
Disodium cocoamphodiacetate ( UNII: 18L9G3U51M)
Ethylparaben ( UNII: 14255EXE39)
Glycerin ( UNII: PDC6A3C0OX)
Isobutylparaben ( UNII: 0QQJ25X58G)
Methylparaben ( UNII: A2I8C7HI9T)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Polysorbate 20 ( UNII: 7T1F30V5YH)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part347 USA

Labeler - Coloplast Corp( 110326675)

Establishment

Name ID/FEI Business Operations
Coloplast Corp 110326675 MANUFACTURE( 11701-628)

Principal display panel - 8 cloth packet

NDC 11701-628-08

Baza Cleanse & Protect ®Cloth
with Dimethicone

Skin Protectant

All-In-One
Perineal Cloth
With Dimethicone

Helps To Prevent
Incontinence-Associated
Dermatitis

CHG compatible

Coloplast

Product #67088
Contents: 8 Disposable Cloths

A14-1963

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