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NDC 63868-0601-04 Petroleum 100 g/100g Details

Petroleum 100 g/100g

Petroleum is a TOPICAL JELLY in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is PETROLATUM.

Product Information

NDC	63868-0601
Product ID	63868-601_4bce9234-1c7f-4766-b247-2174ea69b6cc
Associated GPIs	98600065004050
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	Petroleum
Proprietary Name Suffix	n/a
Non-Proprietary Name	White Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	JELLY
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	g/100g
Substance Name	PETROLATUM
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
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 63868-0601-04 (63868060104)

Pricing Information	N/A
NDC Package Code	63868-601-04
Billing NDC	63868060104
Package	113 g in 1 JAR (63868-601-04)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 684ac03a-f9b1-412d-8ce5-819ca132dc34 Details

Warning

For External Use Only

Active Ingredient

Name Purpose

White Petrolatum 100% USP .............................. Skin Protectant

Inactive Ingredsient

Water

Purpose

Skin Protectant

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away

Uses

Temporarily Protects:

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

Dosage

Applied as needed.

Label

NDC:63868-601-13

INGREDIENTS AND APPEARANCE

PETROLEUM

white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-601
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-601-13	368 g in 1 JAR; Type 0: Not a Combination Product	01/01/2020
2	NDC:63868-601-04	113 g in 1 JAR; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Private Limited		726025211	manufacture(63868-601)

Revised: 1/2020

Document Id: 4bce9234-1c7f-4766-b247-2174ea69b6cc

Set id: 684ac03a-f9b1-412d-8ce5-819ca132dc34

Version: 2

Effective Time: 20200130