Label: PETROLATUM AND LANOLIN ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-098-02 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 16, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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)
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WARNINGS
Warnings
For external use only.
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Do not use on:
- deep or puncture wounds
- serious burns
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When using this product
- do not get into the eyes
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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
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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
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Other information
Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PETROLATUM AND LANOLIN
petrolatum and lanolin ointmentProduct 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
