REPARA- lanolin ointment 
PSS World Medical, Inc.

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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Active Ingredient                            Purpose

Lanolin USP 50% .................. Skin Protectant

Repara Advanced Skincare

Skin Protectant w/ Lanolin

Multi-Purpose

Light Scent

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

Directions

Warnings

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

Inactive Ingredients

beeswax (yellow wax), fragrance, HEEDTA, lanolin alcohol, mineral oil, oxyquinolone, petrolatum, purified water, sodium borate, sorbitan sesquioleate.

Manufactured for PSS World Medical, Inc.

4345 Southpoint Blvd., Jacksonville, FL 32216

Comments or Questions? 800-777-4908

Made in the USA

Other Information

Store at 20oC - 25oC (68oF - 77oF).

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REPARA 
lanolin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68345-818(NDC:12090-0019)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN5 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68345-818-25144 in 1 CARTON
15 g in 1 PACKAGE
2NDC:68345-818-26114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/06/2014
Labeler - PSS World Medical, Inc. (101822682)
Establishment
NameAddressID/FEIBusiness Operations
Summit Industries Inc.003279189manufacture(68345-818)

Revised: 8/2014
Document Id: 1af9e8e1-3f2a-4b9b-93fd-e0588feec24d
Set id: 3e4b7a53-2690-45c8-824f-44a8508d6944
Version: 2
Effective Time: 20140807
 
PSS World Medical, Inc.