PETROLATUM AND LANOLIN ointment

PETROLATUM and LANOLIN by

Drug Labeling and Warnings

PETROLATUM and LANOLIN 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 ingredients                           Purpose
Lanolin 15.5%...................................Skin protectant
Petrolatum 53.4%.............................Skin protectant

PURPOSE

Uses
- helps treat and prevent diaper rash
- temporarily protects minor:
    - cuts     - scrapes    - burns
- temporarily protects and helps relieve chapped
chaffed or cracked skin and lips
- helps protect from the drying effects of wind and
cold weather

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses
- helps treat and prevent diaper rash
- temporarily protects minor:
    - cuts     - scrapes    - burns
- temporarily protects and helps relieve chapped
chaffed or cracked skin and lips
- helps protect from the drying effects of wind and
cold weather

Other information
- store between 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

WARNINGS

Warnings
For external use only.
_______________________________

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

When using this product
- do not get into the eyes
_______________________________

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

DOSAGE & ADMINISTRATION

Directions
-for skin protectional use: apply as needed
- for diaper rash use:
  - change wet and soiled diapers promptly
  - cleanse the diaper area and allow to dry
  - apply ointment liberally as often as necessary, with
    each diaper change, especially at bedtime or anytime
    when exposure to wet diapers may be prolonged
- for other uses: apply as needed
________________________________

Other information

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

INACTIVE INGREDIENT

Inactive Ingredients cod liver oil (contains
vitamin A and vitamin D), daucus carota sativa (carrot)
seed oil, fragrance, microcrystaling wax, mineral oil,
paraffin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PETROLATUM AND LANOLIN 
petrolatum and lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	534 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	155 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MINERAL OIL (UNII: T5L8T28FGP)
COD LIVER OIL (UNII: BBL281NWFG)
CARROT SEED OIL (UNII: 595AO13F11)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-098-02	113 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