ZINC OXIDE WITH MENTHOL AND WHITE PETROLATUM- menthol, zinc oxide, white petrolatum ointment

Zinc Oxide with Menthol and White Petrolatum by

Drug Labeling and Warnings

Zinc Oxide with Menthol and White Petrolatum by is a Otc medication manufactured, distributed, or labeled by Aldermed Inc., Gopaldas Visram and Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 0.44%

Zinc Oxide 20.625%

White Petrolatum USP 66.625%

Purpose

Analgesic

External Analgesic

Astringent/Protectant

Uses

■ gives temporary relief of local itching and discomfort in the perianal area

■ temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues

■ temporarily protects irritated areas 

■ temporarily relieves burning

■ provides temporary relief from skin irritations

■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

■ temporarily protects inflamed perianal skin

■ temporarily relieves the symptoms of perianal skin irritation

■ may provide a cooling sensation

Warnings

For external use only

Allergy Alert: certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

When using this product

■ do not exceed the recommended daily dosage unless directed by a doctor
■ do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

■ condition worsens or does not improve in 7 days
■ bleeding occurs, consult a doctor promptly

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

■ Adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to affected area up to 6 times daily.

■ Children under 12 years of age: consult a doctor

Other Information

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

Inactive Ingredients

Calamine, Glycerine, Lanolin, Mineral Oil, Phenol, Sodium Bicarbonate, Thymol

Questions?

Gopaldas Visram and Company Limited.

Address - A/327, TTC Industrial Area,

MIDC Mahape, Navi Mumbai,

Maharashtra 400710, India

Zinc Oxide, Menthol and White Petrolatum

INGREDIENTS AND APPEARANCE

ZINC OXIDE WITH MENTHOL AND WHITE PETROLATUM 
menthol, zinc oxide, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87236-008
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
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	66.625 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOL (UNII: 339NCG44TV)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87236-008-04	1 in 1 BOX	12/01/2025
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/01/2025

Labeler - Aldermed Inc. (144887712)

Establishment
Name	Address	ID/FEI	Business Operations
Gopaldas Visram and Company Limited		858030888	manufacture(87236-008)