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CeraVe Itch Relief Moisturizing

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 1mg in 1mL
Labeler: VALEANT PHARMACEUTICALS NORTH AMERICA LLC
NDC Code: 0187-1970

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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, 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)

CERAVE ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1970
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL MYRISTATE 
CETYL ALCOHOL 
STEARIC ACID 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
GLYCERIN 
DIMETHICONE 
NIACINAMIDE 
CERAMIDE 3 
CERAMIDE 6 II 
CERAMIDE 1 
HYALURONIC ACID 
PHENOXYETHANOL 
XANTHAN GUM 
BEHENTRIMONIUM METHOSULFATE 
POLYGLYCERYL-3 DIISOSTEARATE 
SODIUM HYDROXIDE 
ALCOHOL 
ALLANTOIN 
ETHYLHEXYLGLYCERIN 
SODIUM LAUROYL LACTYLATE 
ARGININE PYROGLUTAMATE 
EDETATE DISODIUM 
POTASSIUM PHOSPHATE, MONOBASIC 
POTASSIUM PHOSPHATE, DIBASIC 
TASMANNIA LANCEOLATA FRUIT 
ZINC CITRATE 
SODIUM PYRROLIDONE CARBOXYLATE 
PHYTOSPHINGOSINE 
CHOLESTEROL 
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:0187-1970-08237 mL in 1 BOTTLE, PUMP
2NDC:0187-1970-9915 BOTTLE in 1 TRAY
229.6 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/2016
Labeler - VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623)
Establishment
NameAddressID/FEIOperations
Accupac, Inc.071609663MANUFACTURE(0187-1970)

 
VALEANT PHARMACEUTICALS NORTH AMERICA LLC

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Medically reviewed on Feb 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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