MENTHOL AND ZINC OXIDE ointment

Menthol and Zinc Oxide by

Drug Labeling and Warnings

Menthol and Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Purpose

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

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

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

Warnings:

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

Stop use and ask a 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.

Dosage & Administration:

• 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

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

MENTHOL AND ZINC OXIDE 
menthol and zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.44 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20.625 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
THYMOL (UNII: 3J50XA376E)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-013-23	113 g in 1 TUBE; Type 0: Not a Combination Product	08/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/17/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)