CVS ITCH RELIEF MOISTURIZING- pramoxine hcl 1% lotion

CVS Itch relief moisturizing by

Drug Labeling and Warnings

CVS Itch relief moisturizing by is a Otc medication manufactured, distributed, or labeled by CVS Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine Hydrochloride 1%

PURPOSE

External analgesic

INDICATIONS & USAGE

Use for the temporary relief of itching associated with minor skin irritations

WARNINGS

For external use only

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

• animal bites
• severe puncture wounds or burns

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Immediately (1-800-222-1222)

DOSAGE & ADMINISTRATION

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 INGREDIENT

Allantion, Aloe Vera, Arginine PCA, Behenic Acid, Ceramide AP, Ceramide EOP, Ceramide NP, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Isopropyl Palmitate, Niacinamide, PEG 100 Stearate, Phenoxyethanol, Phytosphingosine, Polyglyceryl-2- Diisostearate, polyglyceryl-6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Purified water, Shea Butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Sodium PCA, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Triethyl Citrate, Xanthan Gum, Zinc Citrate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS ITCH RELIEF MOISTURIZING 
pramoxine hcl 1% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE AP (UNII: F1X8L2B00J)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
WATER (UNII: 059QF0KO0R)
SHEA BUTTER (UNII: K49155WL9Y)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
NIACINAMIDE (UNII: 25X51I8RD4)
ZINC CITRATE (UNII: K72I3DEX9B)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALLANTOIN (UNII: 344S277G0Z)
ARGININE (UNII: 94ZLA3W45F)
CERAMIDE 1 (UNII: 5THT33P7X7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-144-01	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/17/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/17/2023

Labeler - CVS Health (062312574)