MENTHOL AND ZINC OXIDE- menthol, 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 Delsam Pharma Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients:

Menthol 0.44%

Zinc Oxide 20.6%

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses:

A moisture barrier that prevents & helps heal skin irritation 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 If condition worsens or does not improve within 7 days, consult a doctor.

Keep out of reach of children In case of accidental ingestion contact a physician or poison control center immediately

Directions:

Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of Menthol and Zinc Oxide 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.

Inactive ingredients:

calamine, cholorothymol, glycerin, lanolin, phenol, sodium bicarbonate, and thymol in a suitable ointment base

Other information:

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

Questions or comments?

1-866-826-1306 between 9 am and 4 pm EST, Monday- Friday.

SPL UNCLASSIFIED SECTION

*Compare to the active ingredient in Calmosetine® Ointment

MULTIPURPOSE MOISTURE BARRIER

PROTECTS, SOOTHES, HELPS PROMOTE HEALING

TEMPORARILY RELIVES DISCOMFORT & ITCHING

LONG-LASTING PROTECTION

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

INGREDIENTS AND APPEARANCE

MENTHOL AND ZINC OXIDE 
menthol, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72570-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	4.4 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	206 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FERRIC OXIDE RED (UNII: 1K09F3G675)
CHLOROTHYMOL (UNII: LJ25TI0CVT)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)

Product Characteristics
Color	white (WHITE TO OFF WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72570-113-42	1 in 1 CARTON	04/10/2019
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 final	part346	04/10/2019

Labeler - Delsam Pharma Llc (081369679)