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NDC 63868-0599-75 Petroleum with Cocoa 100 g/100g Details

Petroleum with Cocoa 100 g/100g

Petroleum with Cocoa 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	63868-0599
Product ID	63868-599_841e0057-93fe-4633-932b-2396ba03fd99
Associated GPIs
GCN Sequence Number	008482
GCN Sequence Number Description	petrolatum,white JELLY (G) TOPICAL
HIC3	U6E
HIC3 Description	OINTMENT/CREAM BASES
GCN	36369
HICL Sequence Number	003774
HICL Sequence Number Description	PETROLATUM,WHITE
Brand/Generic	Generic
Proprietary Name	Petroleum with Cocoa
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 63868-0599-75 (63868059975)

Pricing Information	N/A
NDC Package Code	63868-599-75
Billing NDC	63868059975
Package	212 g in 1 JAR (63868-599-75)
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 280d4bdb-30d3-44f2-9159-3aa9a1de9a5f 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:63868-599-75

INGREDIENTS AND APPEARANCE

PETROLEUM WITH COCOA

white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-599
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
COCOA BUTTER (UNII: 512OYT1CRR)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-599-75	212 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(63868-599)

Revised: 1/2020

Document Id: 841e0057-93fe-4633-932b-2396ba03fd99

Set id: 280d4bdb-30d3-44f2-9159-3aa9a1de9a5f

Version: 1

Effective Time: 20200130