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NDC 53329-0072-96 Soothe and Cool Free Moisture Barrier 92.8 g/100g Details

Soothe and Cool Free Moisture Barrier 92.8 g/100g

Soothe and Cool Free Moisture Barrier is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Medline Industries, LP. The primary component is PETROLATUM.

Product Information

NDC	53329-0072
Product ID	53329-072_e9b0c006-8e8d-c5e5-e053-2995a90adb16
Associated GPIs	90972000004200
GCN Sequence Number	065119
GCN Sequence Number Description	petrolatum/A and D/aloe vera OINT. (G) 92.8% TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	22537
HICL Sequence Number	036283
HICL Sequence Number Description	WHITE PETROLATUM/VITAMINS A AND D/ALOE VERA EXTRACT
Brand/Generic	Brand
Proprietary Name	Soothe and Cool Free Moisture Barrier
Proprietary Name Suffix	n/a
Non-Proprietary Name	Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	92.8
Active Ingredient Units	g/100g
Substance Name	PETROLATUM
Labeler Name	Medline Industries, LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M016
Listing Certified Through	2024-12-31

Package

Package Images

NDC 53329-0072-96 (53329007296)

Pricing Information	N/A
NDC Package Code	53329-072-96
Billing NDC	53329007296
Package	144 PACKET in 1 CARTON (53329-072-96) / 5 g in 1 PACKET (53329-072-16)
Marketing Start Date	2007-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a143042d-5de5-4440-8750-2b56f3b817c6 Details

Active ingredient

Petrolatum 92.8%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes, and burns
temporarily protects and helps chapped or cracked skin and lips
helps treat and prevent diaper rash caused from wetness, urine and/or stool

Warnings

For external use only.

Do not use on

deep or puncture wounds
animal bites
serious burns

When using this product

do not get into eyes

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.

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

Directions

gently cleanse and pat dry affected area
apply ointment as needed

Other information

protect from freezing, avoid excessive heat

Inactive ingredients

aloe barbadensis leaf juice, benzethonium chloride, cholecalciferol (vitamin D3), corn oil, mineral oil, octyl hydroxystearate, propylene glycol, retinyl palmitate (vitamin A)

Manufacturing Information

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA

www.medline.com

1-800-MEDLINE

REF: MSC095384

RK19ULI

Package Label

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL FREE MOISTURE BARRIER

petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-072
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	92.8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53329-072-96	144 in 1 CARTON	01/01/2007
1	NDC:53329-072-16	5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:53329-072-16	5 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M016	01/01/2007

Labeler - Medline Industries, LP (025460908)

Revised: 9/2022

Document Id: e9b0c006-8e8d-c5e5-e053-2995a90adb16

Set id: a143042d-5de5-4440-8750-2b56f3b817c6

Version: 4

Effective Time: 20220927