OTC - ACTIVE INGREDIENT SECTION
Pramoxine HCLI 1.00%
Pramoxine HCLI 1.00%
Topical Analgesic
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
Children under 2 years of age consult a doctor
For external use only
Do not use: in around the eyes; more oftehn than directed; longer than 1 week
When using this product avoid contact with the eyes
Stop and ask a doctor if: sysmptoms persist for more than 7 days; conditions worsens; symptoms clear up and occur again within a few days
Aluminum acetate, aluminum sulfate, water, calcium acetate, cetearyl alcohol, cetearyl olivate, cocos nucifera oil, gluconolactone, glycerin, glyceryl sterate SE, sunflower seed oil, maltodextrin, petrolatum, sodium benzoate, sodium laurylglucosides, hydroxypropylsulfonate, sorbitan olivate, stearic acid, synthetic beeswax.
For the temporary relief of pain and itching associated with: minor burns, minor cuts, scrapes, minor skin irritations
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 334fe8d2-68fb-4331-a576-420e302ec069 | Product name | 7 | 20240320 |
| 0441a8f5-3835-497c-aedd-bc78cba56b2a | Product name | 1 | 20150317 |
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70678-001-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-cf19-f424-e053-dadaa90a57ce | COCOSKIN |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70678-001-01 | COCOSKIN | 118 mL in 1 CANISTER | CREAM | 118 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70678-001 | 70678-001-01 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 30ec5342-bff8-1ad1-e054-00144ff8d46c | 30ec5342-bff7-1ad1-e054-00144ff8d46c | 2016-04-20 | Warnings | 30ec5342-bff8-1ad1-e054-00144ff8d46c 30ec5342-bff7-1ad1-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.