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NDC 00363-0740-13 Shea Butter Petroleum Jelly 99.6 g/100g Details

Shea Butter Petroleum Jelly 99.6 g/100g

Shea Butter Petroleum Jelly is a TOPICAL JELLY in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is PETROLATUM.

Product Information

NDC	00363-0740
Product ID	0363-0740_ab1b1186-4abc-de83-e053-2995a90a77b8
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	Shea Butter Petroleum Jelly
Proprietary Name Suffix	n/a
Non-Proprietary Name	Petrolatum Jelly
Product Type	HUMAN OTC DRUG
Dosage Form	JELLY
Route	TOPICAL
Active Ingredient Strength	99.6
Active Ingredient Units	g/100g
Substance Name	PETROLATUM
Labeler Name	Walgreens
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0740-13 (00363074013)

Pricing Information	N/A
NDC Package Code	0363-0740-13
Billing NDC	00363074013
Package	368 g in 1 JAR (0363-0740-13)
Marketing Start Date	2016-06-14
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e35d913e-2195-4e3d-ae38-f010317140fd Details

Active Ingredient

White Petrolatum USP (99.6%)

Purpose

Skin Protectant

Uses

temporarily protects minor: cuts, scrapes, burns; temporarily protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

condition worsens, symptoms last longer than 7 days or clear up and occur again within a few days

Do not use on

deep or puncture wounds, animal bites, serious burns

Keep out of reach of children.

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

Directions

apply as needed

Inactive ingredients

butyrospermum parkii (shea butter), fragrance

Questions or comments?

1-800-925-4733

Label

INGREDIENTS AND APPEARANCE

SHEA BUTTER PETROLEUM JELLY

petrolatum jelly jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0740
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)	0.1 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:0363-0740-13	368 g in 1 JAR; Type 0: Not a Combination Product	06/14/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/14/2016

Labeler - Walgreens (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack, Inc.		009248480	manufacture(0363-0740)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(0363-0740)

Revised: 7/2020

Document Id: ab1b1186-4abc-de83-e053-2995a90a77b8

Set id: e35d913e-2195-4e3d-ae38-f010317140fd

Version: 3

Effective Time: 20200723