PETROLATUM AND LANOLIN - petrolatum and lanolin ointment 
CVS

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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drug facts

Active ingredients                           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
chaffed or cracked skin and lips
- helps protect from the drying effects of wind and
cold weather

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

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
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


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

Label
PETROLATUM AND LANOLIN 
petrolatum and lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM534 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN155 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
COD LIVER OIL (UNII: BBL281NWFG)  
CARROT SEED OIL (UNII: 595AO13F11)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-098-02113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/19/2009
Labeler - CVS (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: eea14fa9-9c3c-4b8a-b8d0-3bdd468dd7ff
Set id: 52b8ff16-c431-411f-a068-24df8579c2d4
Version: 6
Effective Time: 20110216
 
CVS