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NDC 43749-0231-02 Moisture Barrier 98.3 g/100g Details

Moisture Barrier 98.3 g/100g

Moisture Barrier is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Unipack LLC. The primary component is PETROLATUM.

Product Information

NDC	43749-0231
Product ID	43749-231_e1c393e3-3293-59d3-e053-2a95a90aed70
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	Moisture Barrier
Proprietary Name Suffix	n/a
Non-Proprietary Name	Moisture Barrier Ointment
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	98.3
Active Ingredient Units	g/100g
Substance Name	PETROLATUM
Labeler Name	Unipack LLC
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 43749-0231-02 (43749023102)

Pricing Information	N/A
NDC Package Code	43749-231-02
Billing NDC	43749023102
Package	56 g in 1 TUBE (43749-231-02)
Marketing Start Date	2018-02-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7a476687-d836-4775-9a8d-b9192b5955a0 Details

Active Ingredient

White Petrolatum 98.3%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, and burns

Temporarily protects and helps relieve chapped or cracked skin

Helps treat and prevent diaper rash caused from wetness, urine and/or stool

Warnings

For external use only

Do not use on

Do not use on - deep or puncture wounds - animal bites - serious burns - an area that is infected

When using this product

When using this product - do not get into eyes

Stop use and ask a doctor if

Stop use and ask a doctor if - condition worsens - symptoms last for more than 7 days or clear up and occur again within a few days

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.

Directions

Gently cleanse and pat dry affected area

Apply as needed

Inactive ingredients

aloe extract, benzethonium chloride, cholecalciferol (vitamin D), cococaprylate / caprate, corn oil, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E).

Other information

Protect from freezing. Avoid excessive heat.

Label

INGREDIENTS AND APPEARANCE

MOISTURE BARRIER

moisture barrier ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43749-231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	98.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)	0.993 g in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744)	0.004 g in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.5 g in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 g in 100 g
CORN OIL (UNII: 8470G57WFM)	0.1 g in 100 g
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)	0.002 g in 100 g
CHOLECALCIFEROL (UNII: 1C6V77QF41)	0.001 g in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43749-231-02	56 g in 1 TUBE; Type 0: Not a Combination Product	02/03/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/03/2018

Labeler - Unipack LLC (009248480)

Registrant - Unipack LLC (116015769)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack LLC		009248480	manufacture(43749-231)

Revised: 6/2022

Document Id: e1c393e3-3293-59d3-e053-2a95a90aed70

Set id: 7a476687-d836-4775-9a8d-b9192b5955a0

Version: 3

Effective Time: 20220618