Calmodrox Ointment

Manufacturer: Geritrex Corp
Effective date: 2015-02-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:41:41

Label at a glance#

ProductCalmodrox

Active ingredientMENTHOL, ZINC OXIDE

Label structure9 sections

Indications and uses

A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

Dosage and administration

Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection

Storage and handling

Store at room temperature 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Menthol 0.44% External analgesic

First aid antiseptic antipruritic

Zinc Oxide 20.0% Skin protectant/moisture barrier

Uses

OTC - PURPOSE SECTION

Directions

INDICATIONS & USAGE SECTION

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Not for deep or puncture wounds

Avoid contact with eyes

If condition worsens or does not improve within 7 days, consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In the event of accidental ingestion contact a Poison Control Center right away

Storage

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C (59°-86°F)

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label of Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
744868	menthol 0.44 % / zinc oxide 20 % Topical Ointment	PSN	1
1549717	menthol 0.0044 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment [Calmodrox]	SBD	1
744868	menthol 0.0044 MG/MG / zinc oxide 0.2 MG/MG Topical Ointment	SCD	1
744868	Menthol 0.0044 MG/MG / ZNO 0.2 MG/MG Topical Ointment	SY	1
1549717	Menthol 0.0044 MG/MG / ZNO 0.2 MG/MG Topical Ointment [Calmodrox]	SY	1
744868	menthol 0.44 % / zinc oxide 20 % Topical Ointment	SY	1

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0354162219047	GTIN-13: 0354162219047 EAN-13: 0354162219047 GTIN-12: 354162219047 UPC-A: 354162219047 GTIN storage (14 digits): 00354162219047	CXT4.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54162-219-04	2020-01-31	C162847	48780-1	9d75b9d0-b1fa-f424-e053-dadaa90a57ce	Calmodrox Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-219-04	Calmodrox	113 g in 1 TUBE	OINTMENT	113		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-219	CALMODROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX CORP]	1	Legacy NDC, 1 package rows	20150212_724ac9d2-8567-43cc-9eb2-e83fbb542a87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-219-04	GM - Gram	54162-219	e5ed7033-b4f5-4802-a40f-260be19a68db	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Calmodrox
Menthol, Zinc Oxide
MENTHOL
ZINC OXIDE
GLYCERIN
LANOLIN
PHENOL
SODIUM BICARBONATE
THYMOL
SODIUM LAURETH SULFATE
METHYLPARABEN
PROPYLPARABEN
DMDM HYDANTOIN
STEARYL ALCOHOL
PROPYLENE GLYCOL
SORBITAN SESQUIOLEATE
MINERAL OIL
PETROLATUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54162-219	54162-219-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
PHENOL	339NCG44TV	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
THYMOL	3J50XA376E	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
WATER	059QF0KO0R	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 8 · 435 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	TABLET / ORAL		20 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITAN SESQUIOLEATE	SORBITAN SESQUIOLEATE	0W8RRI5W5A	OINTMENT / RECTAL		15 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM BICARBONATE	SODIUM BICARBONATE	8MDF5V39QO	CAPSULE, DELAYED RELEASE PELLETS / ORAL		4 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	CAPSULE, EXTENDED RELEASE / ORAL	72 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SOLUTION / SUBCUTANEOUS	0.55 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CLOTH / TOPICAL	0.05 mg/mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRADERMAL	0.25 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii candidate 79 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
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	LIQUID / SUBCUTANEOUS	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRA-ARTICULAR	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		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
8e3d4a50-2206-4132-890c-9c08296e62bb			724ac9d2-8567-43cc-9eb2-e83fbb542a87	2015-02-12	Warnings	Exact identifier spl id: 8e3d4a50-2206-4132-890c-9c08296e62bb spl set id: 724ac9d2-8567-43cc-9eb2-e83fbb542a87

Reported adverse events (FAERS/openFDA)#

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