Repara: Package Insert and Label Information

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.

Active Ingredient Purpose

Lanolin USP 50% ……………… Skin Protectant

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.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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: 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 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).

label image
(click image for full-size original)

label 2 image
(click image for full-size original)
REPARA
lanolin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68345-818(NDC:12090-0019)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LANOLIN (LANOLIN) LANOLIN 5 g in 10 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID
LANOLIN ALCOHOLS
MINERAL OIL
OXYQUINOLINE
PETROLATUM
WATER
SODIUM BORATE
SORBITAN SESQUIOLEATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68345-818-25 144 PACKAGE in 1 CARTON contains a PACKAGE
1 5 g in 1 PACKAGE This package is contained within the CARTON (68345-818-25)
2 NDC:68345-818-26 114 g in 1 TUBE None
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 Operations
Summit Industries Inc. 003279189 manufacture (68345-818)

Revised: 08/2014 PSS World Medical, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.