Menthol and Zinc Oxide

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:14:17

Label at a glance#

ProductMenthol and Zinc Oxide

Active ingredientMENTHOL, ZINC OXIDE

Label structure9 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Purpose

OTC - PURPOSE SECTION

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

uses

INDICATIONS & USAGE SECTION

A moisture barrier that prevents and helps heal skin irritations from;

urine
diarrhea
perspiration
fistula drainage
feeding tube site leakage
wound drainage (peri-wound skin)
minor burns
cuts
scrapes
itching

Warnings:

WARNINGS SECTION

■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■Condition worsens

■Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

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.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

Clean skin with mild skin cleanser
Pat dry or allow to air dry
Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calamine, Glycerine, Lanolin, Light Liquid Parafﬁn, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	PSN	2
2123045	menthol 0.0044 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment	SCD	2
2123045	Menthol 0.0044 MG/MG / ZNO 0.206 MG/MG Topical Ointment	SY	2
2123045	menthol 0.44 % / zinc oxide 20.6 % Topical Ointment	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-013-23	2024-06-25	C162847	48780-1	1030e364-f939-111a-e063-dadaa90a10e2	ASTONEA Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant
77338-013-23	2024-01-30	C162847	48780-1	1030e364-f939-111a-e063-dadaa90a10e2	ASTONEA Tender Calm Menthol 0.44% w/w…………….……External Analgesic Zinc Oxide 20.625% w/w………………. Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-013-23	Menthol and Zinc Oxide	113 g in 1 TUBE	OINTMENT	113		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-013	MENTHOL AND ZINC OXIDE OINTMENT [ASTONEA LABS PRIVATE LIMITED]	2	Legacy NDC, 1 package rows	20240627_e67673ba-333c-6bf6-e053-2a95a90a69fb.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Menthol and Zinc Oxide
LANOLIN
LIGHT MINERAL OIL
.ALPHA.-TOCOPHEROL ACETATE
THYMOL
PETROLATUM
MENTHOL
ZINC OXIDE
GLYCERIN
FERRIC OXIDE RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-013	77338-013-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LANOLIN	7EV65EAW6H	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
THYMOL	3J50XA376E	IACT
PETROLATUM	4T6H12BN9U	IACT
MENTHOL	L7T10EIP3A	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
FERRIC OXIDE RED	1K09F3G675	IACT

Source Document#

Source XML

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
1bbb0f72-458c-21f8-e063-6294a90a486f			e67673ba-333c-6bf6-e053-2a95a90a69fb	2024-06-25	Warnings	Exact identifier spl id: 1bbb0f72-458c-21f8-e063-6294a90a486f spl set id: e67673ba-333c-6bf6-e053-2a95a90a69fb

Reported adverse events (FAERS/openFDA)#

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