Indications and uses
temporarily relieves the pain and itch associated with . minor cuts . sunburn . insect bites . scrapes . prickly heat . minor burns . rashes . minor skin irritations . dries the oozing of poison ivy . oak and sumac
temporarily relieves the pain and itch associated with . minor cuts . sunburn . insect bites . scrapes . prickly heat . minor burns . rashes . minor skin irritations . dries the oozing of poison ivy . oak and sumac
adults and children 2 years and older, apply freely up to 3 or 4 times daily children under 2 years, ask a doctor For best results dry skin thoroughly before applying
Menthol 0.17%
Anti-Itch
Zinc Oxide 1.7%
Skin Protectant
temporarily relieves the pain and itch associated with . minor cuts . sunburn . insect bites . scrapes . prickly heat . minor burns . rashes . minor skin irritations . dries the oozing of poison ivy . oak and sumac
For external use only.
avoid contact with eyes
condition worsens. symptoms do not get better within 7 days
In case of accidental ingestion, get medical help or conatct a Poison Control Center right away.
adults and children 2 years and older, apply freely up to 3 or 4 times daily
children under 2 years, ask a doctor
For best results dry skin thoroughly before applying
talc, acacia, methyl salicylate, thymol, zinc stearate, eucalyptol
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43345-002-01 | 2020-10-12 | C162847 | 48780-1 | 9d75b9d0-c00d-f424-e053-dadaa90a57ce | Drug Facts |
| 43345-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c00d-f424-e053-dadaa90a57ce | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 2 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 2 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 2 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 2 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 2 | |
| EUCALYPTOL | INACTIVE INGREDIENT | RV6J6604TK | 2 | |
| METHYL SALICYLATE | INACTIVE INGREDIENT | LAV5U5022Y | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 2 | |
| THYMOL | INACTIVE INGREDIENT | 3J50XA376E | 2 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 43345-002 | 43345-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| TALC | 7SEV7J4R1U | IACT |
| ACACIA | 5C5403N26O | IACT |
| METHYL SALICYLATE | LAV5U5022Y | IACT |
| THYMOL | 3J50XA376E | IACT |
| ZINC STEARATE | H92E6QA4FV | IACT |
| EUCALYPTOL | RV6J6604TK | IACT |
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 |
|---|---|---|---|---|---|---|
| ACACIA | ACACIA | 5C5403N26O | TABLET / ORAL | 70 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | TABLET / ORAL | 10 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, FILM COATED / ORAL | 0.14 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | OINTMENT / TOPICAL | NA | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | CREAM / TOPICAL | 6 %w/w | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET, COATED / ORAL | 1.82 mg | ||
| THYMOL | THYMOL | 3J50XA376E | LIQUID / RESPIRATORY (INHALATION) | 0.01 %w/w | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, EXTENDED RELEASE / ORAL | 34.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | SOLUTION / NASAL | 0.2 mg/1ml | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, COATED / ORAL | 156 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET / SUBLINGUAL | 9.1 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION, EXTENDED RELEASE / ORAL | 46 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET, EXTENDED RELEASE / ORAL | 36 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | SOLUTION / DENTAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 60 mg | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, FOR SUSPENSION / ORAL | 296 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / SUBLINGUAL | 2.5 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | CAPSULE / ORAL | 16 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| ACACIA | ACACIA | 5C5403N26O | LOZENGE / ORAL | 108 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / SUBLINGUAL | 32.4 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE / ORAL | 202 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| ACACIA | ACACIA | 5C5403N26O | CAPSULE / ORAL | 20 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER, DENTIFRICE / DENTAL | NA | ||
| ACACIA | ACACIA | 5C5403N26O | SYRUP / ORAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | SHAMPOO / TOPICAL | 2 %w/w | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | PASTE, DENTIFRICE / DENTAL | 1.1 %w/w | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET / BUCCAL | 9.1 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | CAPSULE / ORAL | 2.04 mg | ||
| THYMOL | THYMOL | 3J50XA376E | POWDER, FOR SOLUTION / ORAL | NA | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | DOUCHE / VAGINAL | 0.05 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, EXTENDED RELEASE / ORAL | 5119 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | LOZENGE / ORAL | 53 mg | ||
| TALC | TALC | 7SEV7J4R1U | ELIXIR / ORAL | 4.5 mg/5ml | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, CHEWABLE / ORAL | 121 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | PASTE, DENTIFRICE / DENTAL | 2.4 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / ORAL | 1000 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED / ORAL | 87 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | JELLY / NASAL | 68.5 mg | ||
| TALC | TALC | 7SEV7J4R1U | SUSPENSION / ORAL | 234 mg | ||
| METHYL SALICYLATE | METHYL SALICYLATE | LAV5U5022Y | POWDER / TOPICAL | NA | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | DROPS / OPHTHALMIC | 0.02 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, DELAYED RELEASE PARTICLES / ORAL | 56 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| ACACIA | ACACIA | 5C5403N26O | POWDER / ORAL | 800 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| EUCALYPTOL | EUCALYPTOL | RV6J6604TK | DROPS / NASAL | 0.2 mg/1ml |
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 |
|---|---|---|---|---|---|---|
| b17eb618-1de1-26bb-e053-2995a90a380f | 4af54ece-3875-481b-9c72-8b4fcc074f44 | 2020-10-12 | Warnings | 4af54ece-3875-481b-9c72-8b4fcc074f44 |
Adverse event summaries are temporarily unavailable. Other product information remains available.