CERAVE ITCH RELIEF MOISTURIZING- pramoxine hydrochloride lotion

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, isopropyl myristate, cetyl alcohol, stearic acid, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, glycerin, dimethicone, niacinamide, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, phenoxyethanol, xanthan gum, behentrimoium methosulfate, polyglyceryl-3 diisostearate, sodium hydroxide, alcohol denat., allantoin, ethylhexylglycerin, sodium lauroyl lactylate, arginine PCA,

disodium EDTA, potassium phosphate, dipotassium phosphate, tasmannia lanceolata fruit extract, zinc citrate, sodium PCA, phytosphingosine, cholesterol, carbomer, tocopheryl acetate

Questions

Toll-Free Number 800-321-4576

www.cerave.com

Principal Display Panel

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

Itch Relief

Moisturizing

Lotion

PRAMOXINE HYDROCHLORIDE 1%

Fast acting, long lasting

With ceramides

Relieves itch and irritation from:

[check mark icon] Dry skin

[check mark icon] Insect bites

[check mark icon] Sunburn

STEROID FREE

[icon - National Eczema Association Seal]

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

CERAVE ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1970
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
HYALURONIC ACID (UNII: S270N0TRQY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
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)
TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1970-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/01/2016
2	NDC: 0187-1970-99	15 in 1 TRAY	02/01/2016
2		29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/18/2016

Labeler - VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc.		071609663	MANUFACTURE(0187-1970)