Label: REPARA- lanolin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68345-818-25, 68345-818-26 - Packager: PSS World Medical, Inc.
- This is a repackaged label.
- Source NDC Code(s): 12090-0019
- Category: HUMAN OTC DRUG LABEL
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 August 7, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
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INDICATIONS & USAGE
Indications: Intended to help protect chafed skin or minor skin irritations, as well as to prevent diaper dermatitis.
Precautions: FOR EXTERNAL USE ONLY. Discontinue use should irritation occur. Do not use on deep puncture wounds, animal bites, and serious burns.
Frequency: Daily.
Uses
- Helps prevent diaper dermatitis.
- Protects chafed skin or minor skin irritations due to incontinence and helps seal out wetness.
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REPARA
lanolin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-818(NDC:12090-0019) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 5 g in 10 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID (UNII: R79J91U341) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) MINERAL OIL (UNII: T5L8T28FGP) OXYQUINOLINE (UNII: 5UTX5635HP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68345-818-25 144 in 1 CARTON 1 5 g in 1 PACKAGE 2 NDC:68345-818-26 114 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/06/2014 Labeler - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Summit Industries Inc. 003279189 manufacture(68345-818)