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 RiteAid, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                   Purpose

Lanolin 15.5% ..................................................Skin protectant
Petrolatum 53.4%.............................................Skin protectant

PURPOSE

Active ingredient                                     Purpose

Lanolin 15.5% ..................................................Skin protectant
Petrolatum 53.4%.............................................Skin protectant

Uses

- Helps treat and prevent diaper rash

- temporarily protects minor - cuts - scrapes - burns

- temporarily protects and helps relieve chapped, chafed 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 the 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, chafed or cracked skin and lips

- helps protect from the drying  effects of wind and cold weather

WARNINGS

Warnings

For external use only.

Do not use on:

- deep or puncture wounds
- animal bites - serious burns

When using this product - Do not get into 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

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

DOSAGE & ADMINISTRATION

Directions

- for skin protectant 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 necessarry with
each diaper change, especially at bedtime or anytime
when exposure to wet diapers may be prolonged

Other information

Store between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

INACTIVE INGREDIENT

Inactive ingredients cod liver oil (contains vitamin A and vitamin D)
daucus carota (carot) seed oil, fragrance, microcrystalline 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: 11822-0684
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	.534 g  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	.155 g  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: 11822-0684-1	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 - RiteAid (014578892)

Registrant - Pharma Pac, LLC (140807475)

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