CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING- pramoxine hydrochloride lotion 
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, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

Questions?

Toll-Free Number 888-768-2915

www.cerave.com

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CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-970
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALLANTOIN (UNII: 344S277G0Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
ARGININE PYROGLUTAMATE (UNII: 808T94CEU6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
PALMITIC ACID (UNII: 2V16EO95H1)  
HYALURONIC ACID (UNII: S270N0TRQY)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-970-01237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/17/2017
2NDC:49967-970-0215 in 1 TRAY08/17/2017
229.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49967-970-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
4NDC:49967-970-04562 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/17/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC624244349manufacture(49967-970) , pack(49967-970)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.960317444manufacture(49967-970) , pack(49967-970)
Establishment
NameAddressID/FEIBusiness Operations
Accupac, LLC061595175manufacture(49967-970)

Revised: 12/2023
Document Id: bfa588fc-1ec8-4d3d-a2cc-cc5e2b1ae277
Set id: 13ce57d0-b1c5-4685-ad7d-a562d9d8fc86
Version: 8
Effective Time: 20231231
 
L'Oreal USA Products Inc