Dr. Smiths Rash and Skin
- Manufacturer
- Mission Pharmacal Company
- Effective date
- 2013-04-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:35:18
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
| Active Ingredient | Purpose |
| Petrolatum 57% | Skin Protectant |
| Lanolin 16% | Skin Protectant |
OTC - PURPOSE SECTION
Uses
temporarily protest minor:
- cuts
- scrapes
- burns
INDICATIONS & USAGE SECTION
Temporarily protects and helps relieve chapped, chafed, or cracked skin.
Helps protect from the dying effects of wind and cold weather.
Helps treat and prevent rash caused by adult incontinence.
WARNINGS SECTION
Warnings
For external use only.
OTC - WHEN USING SECTION
When using this product, avoid contact with eyes.
OTC - ASK DOCTOR SECTION
See a doctor if condition lasts more than 7 days.
OTC - DO NOT USE SECTION
- deep or puncture wounds
- animal bites
- serious burns
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
OTC - PURPOSE SECTION
Directions
Apply as needed to affected area.
OTC - QUESTIONS SECTION
Other Information
Store at 20° – 25°C (68° – 77° F)
INACTIVE INGREDIENT SECTION
beeswax, mineral oil, olive oil, paraffin wax, purified water, thymol iodide, zinc oxide.
OTC - STOP USE SECTION
To report a serious adverse event or obtain product information, call (210) 696-8400
MISSION PHARMACAL COMPANY
San Antonio, TX 78230-1355
51023
Rev 011120
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0178-0370-03 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e330-cd31-e053-dbdaa90ab51a | Dr. Smith's ® Rash+Skin |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0178-0370-03 | Dr. Smiths Rash and Skin | 1 in 1 CARTON | OINTMENT | 1 | 1 | |
| 0178-0370-03 | Dr. Smiths Rash and Skin | 100 g in 1 TUBE | OINTMENT | 100 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0178-0370-03 | GM - Gram | 0178-0370 | 90efafb9-c964-4679-848a-038b5330fbe0 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| OLIVE OIL | INACTIVE INGREDIENT | 6UYK2W1W1E | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| THYMOL IODIDE | INACTIVE INGREDIENT | A51HJM3XSU | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| WHITE WAX | INACTIVE INGREDIENT | 7G1J5DA97F | 1 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr. Smiths Rash and Skin
- Zinc Oxide
- PETROLATUM
- LANOLIN
- MINERAL OIL
- WATER
- WHITE WAX
- OLIVE OIL
- THYMOL IODIDE
- PARAFFIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0178-0370 | 0178-0370-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| ZINC OXIDE | SOI2LOH54Z | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
| WHITE WAX | 7G1J5DA97F | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| THYMOL IODIDE | A51HJM3XSU | IACT |
| PARAFFIN | I9O0E3H2ZE | 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 | TABLET / ORAL | 113.75 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SUPPOSITORY / RECTAL | 375 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / INTRAVENOUS | 3.11 %w/v | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / TOPICAL | 500 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | CAPSULE / ORAL | NA | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM / VAGINAL | 40 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CAPSULE, EXTENDED RELEASE / ORAL | 71 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION, SUSPENSION / SUBCUTANEOUS | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT / TOPICAL | 2100 mg | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | INJECTION / SUBCUTANEOUS | 0.02 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | SOAP / TOPICAL | 0.4 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | CREAM, AUGMENTED / TOPICAL | 10 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / RECTAL | 38 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | OINTMENT, AUGMENTED / TOPICAL | 429 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, DELAYED RELEASE / ORAL | 5.67 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | LOTION / TOPICAL | 16 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| WHITE WAX | WHITE WAX | 7G1J5DA97F | SUPPOSITORY / RECTAL | 265 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | SUSPENSION / TOPICAL | 11726 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / AURICULAR (OTIC) | NA | ||
| ZINC OXIDE | ZINC OXIDE | SOI2LOH54Z | SOLUTION / RESPIRATORY (INHALATION) | 3.11 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | SOLUTION / ORAL | 425 mg/1ml | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | AEROSOL, FOAM / TOPICAL | 14235 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| OLIVE OIL | OLIVE OIL | 6UYK2W1W1E | LOTION / TOPICAL | 32468 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CREAM / TOPICAL | 300 mg |
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 |
|---|---|---|---|---|---|---|
| e6e61eea-73a0-3936-c648-b87771c24102 | e6e61eea-73a0-3936-c648-b87771c24102 | 2013-04-03 | Warnings | e6e61eea-73a0-3936-c648-b87771c24102 e6e61eea-73a0-3936-c648-b87771c24102 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

