CLASSIC CARE PETROLEUM- white petrolatum jelly

Classic Care Petroleum by

Drug Labeling and Warnings

Classic Care Petroleum by is a Otc medication manufactured, distributed, or labeled by FDN Enterprises, LLC, ORCHID LIFESCIENCES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

White Petrolatum USP (99.9%)

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.

Do not use on  deep or puncture wounds  laceration or infections  animal bites  serious burns

Stop use and ask doctor if condition lasts more than 7 days.

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

Water 

SPL UNCLASSIFIED SECTION

PETROLEUM JELLY/ VASELINE

Unscented

Distributed by:

FDN Enterprises, LLC.

Opa Locka, FL 33054.

Made In India

Packaging

INGREDIENTS AND APPEARANCE

CLASSIC CARE PETROLEUM 
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60691-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.9 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60691-130-01	1 in 1 BOX	09/15/2021
1		510 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/15/2021

Labeler - FDN Enterprises, LLC (965743867)

Establishment
Name	Address	ID/FEI	Business Operations
ORCHID LIFESCIENCES		675474890	manufacture(60691-130)