Indications and uses
Temporarily reduces cough due to minor bronchial irritation associated with the common cold.
Temporarily reduces cough due to minor bronchial irritation associated with the common cold.
Adults and children 2 to under 12 years of age • Rub on throat and chest as a thick layer. The area of application may be covered with a warm, dry cloth if desired. Clothing should be left loose about the throat and chest to help the vapor rise to reach the nose and mouth. • Application may be repeated up to three times daily or as directed by a doctor • Consult a doctor for children under 2 years of age
Camphor 5.3%
Menthol 2.8%
Antitussive
Antitussive
Temporarily reduces cough due to minor bronchial irritation associated with the common cold.
A persistent cough maybe a sign of a serious condition. For External Use Only. Do not take by mouth or place in nostrils.
• cough persists for more than 1 week
• tends to recur
• is accompanied by fever, rash, or persistent headache.
If case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Adults and children 2 to under 12 years of age
• Rub on throat and chest as a thick layer. The area of application may be covered with a warm, dry cloth if desired. Clothing should be left loose about the throat and chest to help the vapor rise to reach the nose and mouth.
• Application may be repeated up to three times daily or as directed by a doctor
• Consult a doctor for children under 2 years of age
petrolatum, paraffin
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66513-222-01 | 2019-11-14 | C162847 | 48780-1 | 960f7f55-d08e-8e05-e053-dbdaa90a074a | DRUG FACTS |
| 66513-222-01 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d08e-8e05-e053-dbdaa90a074a | DRUG FACTS |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAMPHOR (NATURAL) | ACTIVE INGREDIENT | N20HL7Q941 | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| CAMPHOR (NATURAL) | ACTIVE MOIETY | N20HL7Q941 | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66513-222 | 66513-222-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PETROLATUM | 4T6H12BN9U | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| CAMPHOR (NATURAL) | N20HL7Q941 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
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 |
|---|---|---|---|---|---|---|
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | AEROSOL, FOAM / TOPICAL | 14235 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET, EXTENDED RELEASE / ORAL | 0.18 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / RECTAL | 38 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / TOPICAL | 7275 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, DELAYED RELEASE / ORAL | 0.2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | EMULSION / TOPICAL | 7.8 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, COATED / ORAL | 0.07 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / TOPICAL | 2860 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET, EXTENDED RELEASE / ORAL | 321 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | SUSPENSION / TOPICAL | 11726 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CREAM / TOPICAL | 300 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | SOAP / TOPICAL | 0.4 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | TABLET / ORAL | 0.7 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | CAPSULE, EXTENDED RELEASE / ORAL | 100 mg |
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 |
|---|---|---|---|---|---|---|
| 9756ba2b-8bad-09be-e053-2a95a90a0405 | a0b028bd-8c1d-420b-b14d-63cc107ddb82 | 2019-11-14 | Warnings | 9756ba2b-8bad-09be-e053-2a95a90a0405 a0b028bd-8c1d-420b-b14d-63cc107ddb82 |
Adverse event summaries are temporarily unavailable. Other product information remains available.