MENTHOL AND ZINC OXIDE- menthol, zinc oxide ointment

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Delsam Pharma Llc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
External analgesic / Anti-itch Skin protectant / Anorectal astringent 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
Authorization status:
OTC monograph final
Authorization number:
72570-113-42

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

®

MENTHOL AND ZINC OXIDE

menthol, zinc oxide ointment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72570 -113

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

4.4 mg in 1 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

20 6 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

CHLO RO THYMO L (UNII: LJ25TI0 CVT)

GLYCERIN (UNII: PDC6 A3C0 OX)

LANO LIN (UNII: 7EV6 5EAW6 H)

PHENO L (UNII: 339 NCG44TV)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

THYMO L (UNII: 3J50 XA376 E)

Product Characteristics

Color

white (WHITE TO OFF WHITE)

S core

S hap e

S iz e

Delsam Pharma Llc

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72570 -113-42

1 in 1 CARTON

0 4/10 /20 19

1

113 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 4/10 /20 19

Labeler -

Delsam Pharma Llc (081369679)

Revised: 4/2019

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