CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING- pramoxine hydrochloride cream

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient

Pramoxine hydrochloride 1%

Purpose

Topical antipruritic

Warnings

For external use only

Do not use

if you are allergic to any of the ingredients.

When using this product,

avoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or reoccur within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Centre immediately.

Directions

Adults and children 2 years of age and older:

    apply to affected area not more than 3 to 4 times daily

for use on children 2–12 years old, application should be supervised by an adult

Inactive ingredients

Aqua, Glycerin, Petrolatum, Cetyl alcohol, Butyrospermum parkii (shea) butter, Cetearyl alcohol, Glyceryl stearate, PEG-100 stearate, Isopropyl
myristate, Stearic acid, Dimethicone, Palmitic acid, Phenoxyethanol, Behentrimonium methosulfate, Xanthan gum, Sodium hydroxide,
Ethylhexylglycerin, Myristic acid, Sodium lauroyl lactylate, Potassium phosphate, Dipotassium phosphate, Disodium EDTA, Tasmannia lanceolata
fruit/leaf extract, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Hydrolyzed hyaluronic acid, Citric acid, Ceramide EOP.

Questions?

1-888-399-3603 www.Cerave.ca

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MYRISTIC ACID (UNII: 0I3V7S25AW)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
POTASSIUM PHOSPHATE (UNII: B7862WZ632)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
EDETATE SODIUM (UNII: MP1J8420LU)
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARBOMER (UNII: 0A5MM307FC)
HYALURONIC ACID (UNII: S270N0TRQY)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-034-01	340 g in 1 JAR; Type 0: Not a Combination Product	05/19/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		05/19/2026

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	manufacture(82046-034) , pack(82046-034)