CALMAFX MOISTURE BARRIER- menthol, ferric oxide red and zinc oxide ointment 
First Choice Medical Supply

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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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

Warnings

Stop use and ask doctor if :

Directions

When practical, gently cleanse and dry area.

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.jpgSachet calmafxtube.jpgTube

CALMAFX  MOISTURE BARRIER
menthol, calamine, zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Summit Industries, Inc.003279189manufacture(75904-3246)

Revised: 3/2013
Document Id: 5ba9ed70-fdbd-435c-ae6f-b6f14e573bca
Set id: 7b52374e-1119-4145-b87b-96b7212fdc3e
Version: 4
Effective Time: 20130322
 
First Choice Medical Supply