Otc - Active Ingredient
Pramoxine HCLI 1.00%
Cocoskin
FDA Label NDC 70678-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Net Source, Llc for the product Cocoskin (NDC 70678-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, dosage & administration, warnings, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.
Dosage & Administration
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
Warnings
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
Inactive Ingredient
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.
Indications & Usage
For the temporary relief of pain and itching associated with: minor burns, minor cuts, scrapes, minor skin irritations
* Please review the disclaimer below.
