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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68345-818-25 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-5136-60a7-e053-dbdaa90a05bd | 3e4b7a53-2690-45c8-824f-44a8508d6944 |
| 68345-818-26 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-5136-60a7-e053-dbdaa90a05bd | 3e4b7a53-2690-45c8-824f-44a8508d6944 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68345-818-25 | Repara | 5 g in 1 PACKAGE | OINTMENT | 5 | 2 | |
| 68345-818-25 | Repara | 144 in 1 CARTON | OINTMENT | 144 | 2 | |
| 68345-818-26 | Repara | 114 g in 1 TUBE | OINTMENT | 114 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 12090-0019-1 | GM - Gram | 12090-0019 | 4ebfeee7-b3d0-4aa1-9be8-b0847399ad80 | 1 | 2014-02-04 |
| 12090-0019-2 | GM - Gram | 12090-0019 | af894f95-c958-4d84-8146-1ae188446b8f | 1 | 2014-02-04 |
| 12090-0019-3 | GM - Gram | 12090-0019 | 23887fb6-6a81-4346-8056-c031d59ced65 | 1 | 2013-07-02 |
| 12090-0019-4 | GM - Gram | 12090-0019 | 3000b26b-422d-4785-8dac-c32f6b3f60b5 | 1 | 2014-02-04 |
| 12090-0019-5 | GM - Gram | 12090-0019 | 487022b4-cf9b-4fa8-acc2-420b336b0f77 | 1 | 2013-03-03 |
| 12090-0019-6 | GM - Gram | 12090-0019 | d8d81b8c-d20a-4144-98cd-a3dbfab14070 | 1 | 2014-02-04 |
| 12090-0019-7 | GM - Gram | 12090-0019 | eab72b78-f4fc-4323-ac4b-b46ec775cdfa | 1 | 2016-04-04 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LANOLIN | ACTIVE INGREDIENT | 7EV65EAW6H | 2 | |
| LANOLIN | ACTIVE MOIETY | 7EV65EAW6H | 2 | |
| HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID | INACTIVE INGREDIENT | R79J91U341 | 2 | |
| LANOLIN ALCOHOLS | INACTIVE INGREDIENT | 884C3FA9HE | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| OXYQUINOLINE | INACTIVE INGREDIENT | 5UTX5635HP | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | 2 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 2 |
Products#
Every source-derived product name is available through these pages.
- Repara
- Lanolin
- YELLOW WAX
- HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID
- LANOLIN ALCOHOLS
- MINERAL OIL
- OXYQUINOLINE
- PETROLATUM
- WATER
- SODIUM BORATE
- SORBITAN SESQUIOLEATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68345-818 | 68345-818-25, 68345-818-26 |
| 12090-0019 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LANOLIN | 7EV65EAW6H | ACTIB |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| HYDROXYETHYLETHYLENEDIAMINETRIACETIC ACID | R79J91U341 | IACT |
| LANOLIN ALCOHOLS | 884C3FA9HE | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| OXYQUINOLINE | 5UTX5635HP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BORATE | 91MBZ8H3QO | IACT |
| SORBITAN SESQUIOLEATE | 0W8RRI5W5A | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | CREAM / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | SOLUTION / AURICULAR (OTIC) | 0.3 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET / ORAL | 3.22 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | SOLUTION/ DROPS / OPHTHALMIC | 1.1 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE / ORAL | 44 mg | ||
| LANOLIN ALCOHOLS | LANOLIN ALCOHOLS | 884C3FA9HE | OINTMENT / TOPICAL | 452 mg | ||
| LANOLIN ALCOHOLS | LANOLIN ALCOHOLS | 884C3FA9HE | CREAM / TOPICAL | 6 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, DELAYED RELEASE / ORAL | 0.1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | SUSPENSION/ DROPS / OPHTHALMIC | 0.03 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | OINTMENT / TOPICAL | 20 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM / TRANSDERMAL | 11.42 mg | ||
| LANOLIN ALCOHOLS | LANOLIN ALCOHOLS | 884C3FA9HE | LOTION / TOPICAL | 9360 mg | ||
| SORBITAN SESQUIOLEATE | SORBITAN SESQUIOLEATE | 0W8RRI5W5A | OINTMENT / RECTAL | 15 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | EMULSION / OPHTHALMIC | 0.11 %w/v | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1af9e8e1-3f2a-4b9b-93fd-e0588feec24d | 3e4b7a53-2690-45c8-824f-44a8508d6944 | 2014-08-07 | Warnings | 1af9e8e1-3f2a-4b9b-93fd-e0588feec24d 3e4b7a53-2690-45c8-824f-44a8508d6944 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

