OTC - ACTIVE INGREDIENT SECTION
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Active Ingredient (w/w): Pramoxine Hydrochloride 1% ....External Analgesic
Inactive ingredients
Purified Water, Glycerin, Allantoin, Tocopheryl Acetate (Vitamin E), Carbomer, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin
Purpose ............External analgesic
Uses
Temporarily helps reduce discomfort from:
Minor burns, Insect bites, Minor skin irritations, Post-shaving or grooming sensitivity
External itching or rash due to dry skin
Warnings (For external use only)
For external use only
Do not use on large areas of the body or on broken, blistered, or abraded skin
Avoid contact with eyes, mouth and mucous membranes
If pregnant or breast feeding, consult a healthcare provider before use
Stop use and ask a doctor if:
Condition worsens or symptoms persist for more than 7 days
Skin irritation, rash, or allergic reaction occurs
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Adults and children over 12 years:
Apply a thin layer to affected area
not more than 3-4 times daily
Children under 12 years: Consult a doctor before use
Wash hands after application
Store at room temperature (15-30°C/59-86'F)
Tamper evident: Do not use if seal is broken or missing
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85284-008-01 | Numbing cream | 50 g in 1 BOTTLE | CREAM | 50 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85284-008 | 85284-008-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| ETHYLHEXYLGLYCERIN | 147D247K3P | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOMER | 0A5MM307FC | IACT |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| VITAMIN E POLYETHYLENE GLYCOL SUCCINATE | O03S90U1F2 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
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 |
|---|---|---|---|---|---|---|
| 3c404ff7-8b89-9f6b-e063-6294a90a2d91 | 3c404ff7-8b88-9f6b-e063-6294a90a2d91 | 2025-08-13 | Warnings | 3c404ff7-8b89-9f6b-e063-6294a90a2d91 3c404ff7-8b88-9f6b-e063-6294a90a2d91 |
Adverse event summaries are temporarily unavailable. Other product information remains available.