MENTHOL AND ZINC OXIDE- menthol, zinc oxide ointment
Delsam Pharma Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MENTHOL AND ZINC OXIDE OINTMENT

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.

*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

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72570-113-42	1 in 1 CARTON	04/10/2019	03/15/2023
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	04/10/2019	03/15/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: 0663237e-b277-4733-ae8e-457eb81e3ab6

Set id: b5fec3cb-ca6a-4fa1-bed3-dbe86cca4499

Version: 3

Effective Time: 20230315

Delsam Pharma Llc