CalmaFX Moisture Barrier Ointment Drug Facts

Manufacturer: First Choice Medical Supply | Summit Industries, Inc.
Effective date: 2013-03-22
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 22:35:01

Label at a glance#

ProductCalmaFX Moisture Barrier

Active ingredientMENTHOL, FERRIC OXIDE RED, ZINC OXIDE

Label structure11 sections

Indications and 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

Dosage and administration

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.

Storage and handling

Store at 15-30°C (59-86°F)

Contacts and useful links#

PhoneLabel contact800-809-4556

Websitewww.fcms.com

www.fcms.com

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.45%

Calamine 2%

Zinc Oxide 18%

Purpose

OTC - PURPOSE SECTION

External Analgesic, Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.
When using this product
do not get into eyes.

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if :

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Store at 15-30°C (59-86°F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

First Choice Medical Supply

127 Interstate Dr.

Richland, MS 39218

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

Item # 33433

Images of representative artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CalmafxSachet.jpgSachet calmafxtube.jpgTube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1373249	calamine 2 % / menthol 0.45 % / zinc oxide 18 % Topical Ointment	PSN	4
1373254	CalmaFX 2 % / 0.45 % / 18 % Topical Ointment	PSN	4
1373254	calamine 0.02 MG/MG / menthol 0.0045 MG/MG / zinc oxide 0.18 MG/MG Topical Ointment [Calmafx]	SBD	4
1373249	calamine 0.02 MG/MG / menthol 0.0045 MG/MG / zinc oxide 0.18 MG/MG Topical Ointment	SCD	4
1373249	Calamine 0.02 MG/MG / Menthol 0.0045 MG/MG / ZNO 0.18 MG/MG Topical Ointment	SY	4
1373254	Calamine 0.02 MG/MG / Menthol 0.0045 MG/MG / ZNO 0.18 MG/MG Topical Ointment [Calmafx]	SY	4
1373249	calamine 2 % / menthol 0.45 % / zinc oxide 18 % Topical Ointment	SY	4
1373254	CalmaFX (calamine 2 % / menthol 0.45 % / zinc oxide 18 % ) Topical Ointment	SY	4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75904-3246-0	2019-11-27	C162847	48780-1	9855d018-d4a2-cd31-e053-dbdaa90ab51a	CalmaFX Moisture Barrier Ointment Drug Facts
75904-3246-3	2019-11-27	C162847	48780-1	9855d018-d4a2-cd31-e053-dbdaa90ab51a	CalmaFX Moisture Barrier Ointment Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75904-3246-0	CalmaFXMoisture Barrier	113 g in 1 TUBE	OINTMENT	113		4
75904-3246-3	CalmaFXMoisture Barrier	5 g in 1 POUCH	OINTMENT	5		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75904-3246	CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]	4	Legacy NDC, 2 package rows	20130325_7b52374e-1119-4145-b87b-96b7212fdc3e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	4
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	4
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	4
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	4
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	4
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

CalmaFX Moisture Barrier
MENTHOL, CALAMINE, ZINC OXIDE
MENTHOL
FERRIC OXIDE RED
ZINC OXIDE
YELLOW WAX
EDETATE DISODIUM
GLYCERIN
LANOLIN
METHYLPARABEN
MINERAL OIL
PETROLATUM
PROPYLPARABEN
WATER
SODIUM BORATE
SORBITAN SESQUIOLEATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75904-3246	75904-3246-3, 75904-3246-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
FERRIC OXIDE RED	1K09F3G675	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
YELLOW WAX	2ZA36H0S2V	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 373 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM BORATE	SODIUM BORATE	91MBZ8H3QO	CREAM / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5ba9ed70-fdbd-435c-ae6f-b6f14e573bca			7b52374e-1119-4145-b87b-96b7212fdc3e	2013-03-22	Warnings	Exact identifier spl id: 5ba9ed70-fdbd-435c-ae6f-b6f14e573bca spl set id: 7b52374e-1119-4145-b87b-96b7212fdc3e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.