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NDC 69771-0013-23 Menthol and Zinc Oxide .44; 20.625 g/100g; g/100g Details

Menthol and Zinc Oxide .44; 20.625 g/100g; g/100g

Menthol and Zinc Oxide is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by GERI-GENTLE CORPORATION. The primary component is MENTHOL; ZINC OXIDE.

Product Information

NDC	69771-0013
Product ID	69771-013_e673ddce-e647-3c78-e053-2995a90af408
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Menthol and Zinc Oxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol and Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.44; 20.625
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL; ZINC OXIDE
Labeler Name	GERI-GENTLE CORPORATION
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69771-0013-23 (69771001323)

Pricing Information	N/A
NDC Package Code	69771-013-23
Billing NDC	69771001323
Package	113 g in 1 TUBE (69771-013-23)
Marketing Start Date	2022-08-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e673d8bd-2573-9f04-e053-2995a90a172a Details

Active Ingredients

Menthol 0.44% w/w

Zinc Oxide 20.625% w/w

Purpose

Menthol 0.44% w/w…………….……External Analgesic

Zinc Oxide 20.625% w/w………………. Skin Protectant

uses

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:

■For external use only ■Not for deep or puncture wounds ■Avoid contact with eyes

Stop use and ask a doctor if

■Condition worsens

■Symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

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

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

Inactive Ingredients

Calamine, Glycerine, Lanolin, Light Liquid Parafﬁn, Petrolatum, Thymol, Tocopheryl Acetate

Principal Display Panel

INGREDIENTS AND APPEARANCE

MENTHOL AND ZINC OXIDE

menthol and zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69771-013
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
THYMOL (UNII: 3J50XA376E)
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69771-013-23	113 g in 1 TUBE; Type 0: Not a Combination Product	08/17/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/17/2022

Labeler - GERI-GENTLE CORPORATION (080367686)

Revised: 8/2022

Document Id: e673ddce-e647-3c78-e053-2995a90af408

Set id: e673d8bd-2573-9f04-e053-2995a90a172a

Version: 1

Effective Time: 20220817