Calmafxmoisture barrier ointment

Active ingredients

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

External Analgesic, Skin Protectant

Uses

A moisture barrier that prevents and helps protect skin irritations from

  • urine
  • diarrhea
  • perspiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings

  • For external use only.
  • When using this product
  • do not get into eyes.

Otc - ask doctor section

Stop use and ask doctor if :

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

Otc - keep out of reach of children section

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

Directions

When practical, gently cleanse and dry area.

  • Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change.
  • Children under 12 years:Consult a doctor.

Other information

Store at 15-30C (59-86F)

Inactive ingredients:

Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

Questions or comments?

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

800-809-4556 or visit www.fcms.com

Item # 33433

Ingredients and appearance - Product information

Calmafxmoisture barrier ointment- Menthol, calamine, zinc oxide

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 75904-3246
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 4.5 mgin 1 g
Ferric oxide red ( UNII: 1K09F3G675)( Ferric oxide red - UNII: 1K09F3G675 ) 20 mgin 1 g
Zinc oxide ( UNII: SOI2LOH54Z)( Zinc oxide - UNII: SOI2LOH54Z ) 180 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Yellow wax ( UNII: 2ZA36H0S2V)
Edetate disodium ( UNII: 7FLD91C86K)
Glycerin ( UNII: PDC6A3C0OX)
Lanolin ( UNII: 7EV65EAW6H)
Methylparaben ( UNII: A2I8C7HI9T)
Mineral oil ( UNII: T5L8T28FGP)
Petrolatum ( UNII: 4T6H12BN9U)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Sodium borate ( UNII: 91MBZ8H3QO)
Sorbitan sesquioleate ( UNII: 0W8RRI5W5A)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part347 USA

Labeler - First Choice Medical Supply( 117734405)

Establishment

Name ID/FEI Business Operations
First Choice Medical Supply 117734405 manufacture( 75904-3246)

Images of representative artwork

CalmafxSachet.jpgcalmafxtube.jpg