CALMAFX MOISTURE BARRIER- menthol, calamine, zinc oxide ointment

CalmaFX by

Drug Labeling and Warnings

CalmaFX by is a Otc medication manufactured, distributed, or labeled by First Choice Medical Supply, Summit Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

ASK DOCTOR

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

• 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

INGREDIENTS AND APPEARANCE

CALMAFX  MOISTURE BARRIER
menthol, calamine, zinc oxide ointment

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.5 mg  in 1 g
FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	20 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	180 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/28/2011

Labeler - First Choice Medical Supply (117734405)

Registrant - Summit Industries, Inc. (003279189)

Establishment
Name	Address	ID/FEI	Business Operations
Summit Industries, Inc.		003279189	manufacture(75904-3246)