CALMAFX MOISTURE BARRIER - menthol 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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Active Ingredients:

Menthol 0.45%

Zinc Oxide 20%

Purpose

External Analgeis

Skin Protectant/Anorectal (Hemorrhoidal)

Uses

A multi-purpose moisture barrier that aids in protecting irritated skin conditions in the perineum, buttocks lower abdomen and inner thighs due to moisture, occlusion, chafing, or continued contact with urin or feces. Helps relieve local discomfort, burning and itching in the peranal area related anorectal disorders and hemorrhoids. Temporarily relieves pain adn itching due to minor skin burns, minor cuts, scrapes, insect bites, sunburn, minor skin irritations.

Dries oozing and weeping of poison ivy, oak, sumac

Warnings:

For external use only.


When using this product, avoid contact with eyes.

Stop use and ask a doctor if

condition worsens

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

Do not exceed recommended daily dosage unless directed by a doctor.

In case of bleeding, consult a doctor promptly.

Do not put product into rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

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 u p 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 degrees C (59-86 degrees F)


Inactive Ingredients

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

CalmaFX Moisture Barrier Ointment

Soothes, protects and moisturizes Skin

First Choice Medical Supply

Treatment

Net Wt. 4ox (113g)



Questions or comments:

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

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

CalmFX Ointment1

CalmFX Ointment2

CalmFXOintment

CALMAFX MOISTURE BARRIER 
menthol, 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) MENTHOL0.45 g  in 100 g
ZINC OXIDE (ZINC) ZINC OXIDE20 g  in 100 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)

Revised: 12/2010
 
First Choice Medical Supply