CERAVE ITCH RELIEF MOISTURIZING- pramoxine hydrochloride lotion 
Bausch Health US LLC

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.

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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, 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 Lotion 8 oz Labels.jpg
CERAVE ITCH RELIEF MOISTURIZING 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1970
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 NP (UNII: 4370DF050B)  
CERAMIDE AP (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 PIDOLATE (UNII: 808T94CEU6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
DIBASIC POTASSIUM PHOSPHATE (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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1970-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/201608/01/2017
2NDC:0187-1970-9915 in 1 TRAY02/01/201608/01/2017
229.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/18/201608/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2016
Document Id: 66f5504a-6f82-4b10-b3a1-73d2c7d078de
Set id: 5ed6ffe1-3acc-4c31-b315-9642d53e1a52
Version: 2
Effective Time: 20160205
 
Bausch Health US LLC