Repara

Manufacturer
PSS World Medical, Inc. | Summit Industries Inc.
Effective date
2014-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:55

Label at a glance#

ProductRepara
Active ingredientLANOLIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

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

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

WARNINGS SECTION

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 SECTION

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 SECTION

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).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

label 2 imagelabel 2 image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
853167lanolin 50 % Topical OintmentPSN2
853167lanolin 0.5 MG/MG Topical OintmentSCD2
853167lanolin 50 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68345-818-252019-11-27C16284748780-19855e2a2-5136-60a7-e053-dbdaa90a05bd3e4b7a53-2690-45c8-824f-44a8508d6944
68345-818-262019-11-27C16284748780-19855e2a2-5136-60a7-e053-dbdaa90a05bd3e4b7a53-2690-45c8-824f-44a8508d6944

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68345-818-25Repara5 g in 1 PACKAGEOINTMENT52
68345-818-25Repara144 in 1 CARTONOINTMENT1442
68345-818-26Repara114 g in 1 TUBEOINTMENT1142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68345-818REPARA (LANOLIN) OINTMENT [PSS WORLD MEDICAL, INC.]2Legacy NDC, 3 package rows20140807_3e4b7a53-2690-45c8-824f-44a8508d6944.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12090-0019-1GM - Gram12090-00194ebfeee7-b3d0-4aa1-9be8-b0847399ad8012014-02-04
12090-0019-2GM - Gram12090-0019af894f95-c958-4d84-8146-1ae188446b8f12014-02-04
12090-0019-3GM - Gram12090-001923887fb6-6a81-4346-8056-c031d59ced6512013-07-02
12090-0019-4GM - Gram12090-00193000b26b-422d-4785-8dac-c32f6b3f60b512014-02-04
12090-0019-5GM - Gram12090-0019487022b4-cf9b-4fa8-acc2-420b336b0f7712013-03-03
12090-0019-6GM - Gram12090-0019d8d81b8c-d20a-4144-98cd-a3dbfab1407012014-02-04
12090-0019-7GM - Gram12090-0019eab72b78-f4fc-4323-ac4b-b46ec775cdfa12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6H2
LANOLINACTIVE MOIETY7EV65EAW6H2
HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACIDINACTIVE INGREDIENTR79J91U3412
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
OXYQUINOLINEINACTIVE INGREDIENT5UTX5635HP2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO2
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5A2
WATERINACTIVE INGREDIENT059QF0KO0R2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2V2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68345-81868345-818-25, 68345-818-26
12090-0019

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 69 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE, EXTENDED RELEASE / ORAL80.67 mgExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPLOTION / TOPICAL1428 mgExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION / AURICULAR (OTIC)0.3 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / VAGINAL402 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET / ORAL3.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSOAP / TOPICAL0.82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / TOPICAL452 mgExact identifier — unii candidate
4 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HECREAM / TOPICAL6 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, COATED / ORAL1.5 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TRANSDERMAL6.09 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSUSPENSION/ DROPS / OPHTHALMIC0.03 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSPRAY / TOPICAL1379 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOINTMENT / TOPICAL9938 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM / TRANSDERMAL11.42 mgExact identifier — unii candidate
30 equally ranked IID candidates
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HELOTION / TOPICAL9360 mgExact identifier — unii candidate
4 equally ranked IID candidates
SORBITAN SESQUIOLEATESORBITAN SESQUIOLEATE0W8RRI5W5AOINTMENT / RECTAL15 mgExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOEMULSION / OPHTHALMIC0.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
YELLOW WAXYELLOW WAX2ZA36H0S2VTABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUPPOSITORY / RECTALNAExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / DENTAL95 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPGEL / TOPICAL2.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1af9e8e1-3f2a-4b9b-93fd-e0588feec24d3e4b7a53-2690-45c8-824f-44a8508d69442014-08-07WarningsExact identifier
spl id: 1af9e8e1-3f2a-4b9b-93fd-e0588feec24d
spl set id: 3e4b7a53-2690-45c8-824f-44a8508d6944

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.