CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING- pramoxine hydrochloride cream 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Pramoxine hydrochloride 1%

Purpose

External analgesic

Use

For the temporary relief of itching associated with minor skin irritations.

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last 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.

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.

Inactive ingredients


water, glycerin, petrolatum, cetyl alcohol, butyrospermum parkii (shea) butter, cetearyl alcohol, PEG-100 stearate, glyceryl stearate, isopropyl myristate, stearic acid, dimethicone, palmitic acid, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, behentrimonium methosulfate, sodium hydroxide, myristic acid, sodium lauroyl lactylate, cholesterol, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., hydrolyzed hyaluronic acid, citric acid, xanthan gum, hytosphingosine, ethylhexylglycerin

Questions or comments?

Toll-Free Number 888-768-2915

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CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-512
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PALMITIC ACID (UNII: 2V16EO95H1)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-512-01340 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
2NDC:49967-512-02453.6 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
3NDC:49967-512-03538.6 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/18/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, Inc.071609663MANUFACTURE(49967-512)

Revised: 12/2023
Document Id: 61f5c62e-a06b-4e06-868a-db8df7fcb16b
Set id: c6a0880e-fc16-46e9-8314-c56c9d15bf31
Version: 5
Effective Time: 20231231
 
L'Oreal USA Products Inc