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CalmaFX Moisture Barrier

Medically reviewed on Mar 22, 2018

Dosage form: ointment
Ingredients: MENTHOL 4.5mg in 1g, FERRIC OXIDE RED 20mg in 1g, ZINC OXIDE 180mg in 1g
Labeler: First Choice Medical Supply
NDC Code: 75904-3246

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.

CalmaFX Moisture Barrier Ointment Drug Facts

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.

Stop use and ask doctor if :

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

  • 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 15-30°C (59-86°F)

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

Images of representative artwork

CalmafxSachet.jpg calmafxtube.jpg

CALMAFX  MOISTURE BARRIER
menthol, calamine, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75904-3246
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.5 mg  in 1 g
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED20 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE180 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
EDETATE DISODIUM 
GLYCERIN 
LANOLIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
PROPYLPARABEN 
WATER 
SODIUM BORATE 
SORBITAN SESQUIOLEATE 
Packaging
#Item CodePackage Description
1NDC:75904-3246-35 g in 1 POUCH
2NDC:75904-3246-0113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/28/2011
Labeler - First Choice Medical Supply (117734405)
Registrant - Summit Industries, Inc. (003279189)
Establishment
NameAddressID/FEIOperations
Summit Industries, Inc.003279189manufacture(75904-3246)

 
First Choice Medical Supply

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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