Label: PETROLATUM AND LANOLIN ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-0684-1 - Packager: RiteAid
- 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
- INDICATIONS & USAGE
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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.
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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
- 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: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
