COCOSKIN- pramoxine cream 
Net Source, LLC

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.

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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

label

COCOSKIN 
pramoxine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70678-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1.18 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CALCIUM ACETATE (UNII: Y882YXF34X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (UNII: B306V77S6R)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ALUMINUM ACETATE (UNII: 80EHD8I43D)  
ALUMINUM SULFATE (UNII: 34S289N54E)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70678-001-01118 mL in 1 CANISTER; Type 0: Not a Combination Product04/01/2016
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)

Revised: 4/2016
Document Id: 30ec5342-bff8-1ad1-e054-00144ff8d46c
Set id: 30ec5342-bff7-1ad1-e054-00144ff8d46c
Version: 1
Effective Time: 20160420
 
Net Source, LLC