CERAVE ITCH RELIEF MOISTURIZING CREAM- pramoxine hydrochloride cream

CeraVe Itch Relief Moisturizing by

Drug Labeling and Warnings

CeraVe Itch Relief Moisturizing by is a Otc medication manufactured, distributed, or labeled by VALEANT PHARMACEUTICALS NORTH AMERICA LLC, Accupac, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, stearic acid, butyrospermum parkii (shea) butter, cetearyl alcohol, isopropyl myristate, glyceryl stearate, PEG-100 stearate, dimethicone, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, phenoxyethanol, behentrimonium methosulphate, xanthan gum, sodium hydroxide, alcohol denat., ethylhexylglycerin, sodium lauroyl lactylate, disodium EDTA, potassium phosphate, dipotassium phosphate, tasmannia lanceolata fruit exact, phytosphingosine, cholesterol, carbomer

Questions

Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Itch Relief

Moisturizing Cream

PRAMOXINE HYDROCHLORIDE 1%

STEROID FREE

Relieves itch and

irritation from:

[icon – check mark] Dry skin

[icon – check mark] Insect bites

[icon – check mark] Sunburn

[icon - National Eczema Association Seal]

With ceramides

Net Wt. 12 OZ (340 g)

INGREDIENTS AND APPEARANCE

CERAVE ITCH RELIEF MOISTURIZING  CREAM
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1975
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)
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)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
HYALURONIC ACID (UNII: S270N0TRQY)
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)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1975-12	340 g in 1 JAR; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/01/2016

Labeler - VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(0187-1975)