PRAMOXINE ITCH RELIEF- pramoxine hcl 1% cream

Pramoxine Itch relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Pramoxine Hydrochloride 1%

PURPOSE

External Analgesic

INDICATIONS & USAGE

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 persist for 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 (1-800-222-1222)

DOSAGE & ADMINISTRATION

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 INGREDIENT

Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol, Phystosphingosine, Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Shea butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid, Triethanolamine, Triethyl Citrate, Water, Xanthan Gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRAMOXINE ITCH RELIEF 
pramoxine hcl 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-141
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 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE 1 (UNII: 5THT33P7X7)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SHEA BUTTER (UNII: K49155WL9Y)
WATER (UNII: 059QF0KO0R)
CERAMIDE AP (UNII: F1X8L2B00J)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-141-12	340 g in 1 JAR; Type 0: Not a Combination Product	04/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/25/2023

Labeler - CVS (062312574)