PRAMOXINE ITCH RELIEF- pramoxine hcl 1% cream 
CVS

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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CVS Itch Relief Moisturizing Cream

Pramoxine Hydrochloride 1%

External Analgesic

For the temporary relief of itching associated with minor skin irritations

For external use only

When using this product, do not get into eyes

Stop use and ask a doctor if

  • Condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

Directions:

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

Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol, Phystosphingosine, Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Shea butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid, Triethanolamine, Triethyl Citrate, Water, Xanthan Gum

Package Label

PRAMOXINE ITCH RELIEF 
pramoxine hcl 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PETROLATUM (UNII: 4T6H12BN9U)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
SHEA BUTTER (UNII: K49155WL9Y)  
WATER (UNII: 059QF0KO0R)  
CERAMIDE AP (UNII: F1X8L2B00J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-141-12340 g in 1 JAR; Type 0: Not a Combination Product04/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/25/2023
Labeler - CVS (062312574)

Revised: 4/2023
Document Id: fa2d07aa-abac-b533-e053-6294a90a6c7c
Set id: e947694c-c122-0291-e053-2995a90ac39a
Version: 2
Effective Time: 20230425
 
CVS