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COCOSKIN

Medically reviewed on April 20, 2018

Dosage form: cream
Ingredients: PRAMOXINE HYDROCHLORIDE 1.18mg in 1mL
Labeler: Net Source, LLC
NDC Code: 70678-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

COCOSKIN

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

COCOSKIN 
pramoxine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70678-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1.18 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CALCIUM ACETATE 
CETOSTEARYL ALCOHOL 
HELIANTHUS ANNUUS WHOLE 
PETROLATUM 
SODIUM BENZOATE 
SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE 
SORBITAN OLIVATE 
YELLOW WAX 
ALUMINUM ACETATE 
ALUMINUM SULFATE 
GLUCONOLACTONE 
GLYCERIN 
GLYCERYL STEARATE SE 
MALTODEXTRIN 
CETEARYL OLIVATE 
COCOS NUCIFERA WHOLE 
SODIUM LAURYL GLYCOL CARBOXYLATE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:70678-001-01118 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/01/2016
Labeler - Net Source, LLC (080118782)
Registrant - Net Source, LLC (080118782)

 
Net Source, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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