CLASSIC CARE PETROLEUM- petrolatum jelly

Classic Care by

Drug Labeling and Warnings

Classic Care by is a Otc medication manufactured, distributed, or labeled by FDN Enterprises, LLC, Vikshara Trading & Investments Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Petrolatum USP 100%

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

SPL UNCLASSIFIED SECTION

Distributed by:
FDN Enterprises, LLC.
Opa Locka, FL 33054.

PRINCIPAL DISPLAY PANEL - 510 g Jar Label

Unscented

Classic Care®

PETROLEUM JELLY

Skin Protectant

Net Wt 18 Oz (510g)

INGREDIENTS AND APPEARANCE

CLASSIC CARE   PETROLEUM
petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60691-126
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60691-126-34	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	05/30/2011

Labeler - FDN Enterprises, LLC (965743867)

Establishment
Name	Address	ID/FEI	Business Operations
Vikshara Trading & Investments Ltd		675920690	MANUFACTURE(60691-126)