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 Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                         Purpose

Menthol 0.44% v/v                            External Analgesic

                                                          First Aid Antiseptic

                                                          Antipuritic

Zinc Oxide 20.625% v/v                       Skin Protectant

                                                           Moisture Barrier         

Purpose:

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:

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.
  

Indications & Usage

• Not for deep or puncture wounds.
• Avoid contact with eyes.
• If condition worsens or does not improve within 7 days, consult a doctor
  

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
  

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.

Inactive Ingredients

Inactive Ingredients: Calamine, Glycerine, Phenol, Lanolin, Heavy Liquid Paraffin, Sodium Bicarbonate, Thymol, White Soft Paraffin

1271 Label

1275 Label

INGREDIENTS AND APPEARANCE

MENTHOL AND ZINC OXIDE 
menthol and zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-234
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	21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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: 67777-234-01	2 in 1 CASE	05/11/2010
1		144 in 1 BOX
1		3.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67777-234-03	24 in 1 CASE	05/11/2010
2		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 final	part347	05/11/2010

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)