PETROLATUM by CVS / Pharma Pac, LLC PETROLATUM ointment

PETROLATUM by

Drug Labeling and Warnings

PETROLATUM by is a Otc medication manufactured, distributed, or labeled by CVS, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                      Purpose
White petrolatum
60.4%......................................Skin protectant

PURPOSE

Active ingredient                 Purpose
Salicylic Acid
(0.5%)..............................Acne Medication
______________________________________

Use for the management of acne

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.
If swallowed, get medical help or contact
a Poison Control Center immediately.

INDICATIONS & USAGE

Uses
- helps prevent and treat diaper rash
- helps seal out wetness and protects
chafed skin due to diaper rash
-gives temporary relief to chapped,
cracked skin
- offers protection from the drying
effects of wind and cold weather
- gives temporary protection for minor
cuts, scrapes and burns

WARNINGS

Warnings
For external use only.
_______________________________

Do not use on:
- puncture wounds or deep wounds
- animal bites - serious burns
_______________________________

Keep product away from eyes.
_______________________________

Stop use and ask a doctor if:
-condition worsens
-symptoms last more than 7 days; clear
up and occur again within several days

DOSAGE & ADMINISTRATION

Directions
-for diaper rash:
  - change soiled, wet diapers
    immediately
  - cleanse diaper area thoroughly
    and allow to dry
  - liberally apply ointment as often as
    necessary, with each diaper change,
    especially at bedtime or whenever
    exposure to wet diapers may be
    prolonged
- for other uses: apply as needed
________________________________

Other information

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

INACTIVE INGREDIENT

Inactive Ingredients
cholecalciferol, cocoa butter, fragrance,
light mineral oil, mineral oil, modified
lanolin, paraffin, sodium pyruvate,
sunflower seed oil, Vitamin A palmitate,
Vitamin E (di-alpha tocopherol and
di-alpha tocopheryl acetate)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PETROLATUM 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	600 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
COCOA BUTTER (UNII: 512OYT1CRR)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
SODIUM PYRUVATE (UNII: POD38AIF08)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-148-27	99 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/19/2009

Labeler - CVS (062312574)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture