REPARA- lanolin ointment

Repara by

Drug Labeling and Warnings

Repara by is a Otc medication manufactured, distributed, or labeled by PSS World Medical, Inc., Summit Industries Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                            Purpose

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

PURPOSE

Repara Advanced Skincare

Skin Protectant w/ Lanolin

Multi-Purpose

• Contains 50% Lanolin USP
• Skin Barrier for Incontinence Diaper Rash
• Protects chafed or ulcer prone skin

Light Scent

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• Gently cleanse and dry area.
• Apply liberally to affected area as needed.

WARNINGS

Warnings

• For external use only
• When using this product
• do not get into eyes.
• Do not apply to deep or puncture wounds.
• 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.

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

Inactive Ingredients

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

OTHER SAFETY INFORMATION

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REPARA 
lanolin ointment

Product 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)