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CalmaFX

First Choice Medical Supply
Summit Industries, Inc.

CalmaFX Moisture Barrier Ointment Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

External Analgesic, Skin Protectant

CalmaFX 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.jpgCalmaFX calmafxtube.jpgCalmaFX

CalmaFX

MENTHOL, CALAMINE, ZINC OXIDE OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:75904-3246
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 4.5 mg
ferric oxide red 20 mg
Zinc Oxide Zinc oxide 180 mg

Inactive Ingredients

Ingredient Name Strength
YELLOW WAX
EDETATE DISODIUM
GLYCERIN
LANOLIN
METHYLPARABEN
Mineral Oil
petrolatum
PROPYLPARABEN
water
SODIUM BORATE
SORBITAN SESQUIOLEATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75904-3246-3 5 in 1 POUCH
2 NDC:75904-3246-0 113 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2011-02-28


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Be sure to consult your doctor before taking any medication!
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