Discount Drug Mart Medicated Anti itch Cream

Manufacturer: Discount Drug Mart | Weeks and Leo, Inc. | Weeks & Leo, Inc.
Effective date: 2023-12-12
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 00:04:05

Label at a glance#

ProductFreds Medicated anti itch

Active ingredientPRAMOXINE HYDROCHLORIDE, MENTHOL

Label structure9 sections

Indications and uses

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Dosage and administration

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: consult a doctor

Storage and handling

store at controlled room temperature

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Pramoxine hydrochloride 1%

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

Purpose

OTC - PURPOSE SECTION

Topical anagesic

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

STORAGE AND HANDLING SECTION

store at controlled room temperature

Directions

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: consult a doctor

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1116155	menthol 1 % / pramoxine HCl 1 % Topical Cream	PSN	6
1116155	menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	6
1116155	menthol 1 % / pramoxine hydrochloride 1 % Topical Cream	SY	6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-265-01	2023-12-12	C162847	48780-1	ba0f9c33-5871-a910-e053-dadaa90a0b85	Discount Drug Mart Medicated Anti itch Cream
53943-265-01	2021-01-29	C162847	48780-1	ba0f9c33-5871-a910-e053-dadaa90a0b85	Discount Drug Mart Medicated Anti itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-265-01	Freds Medicated anti itch	1 in 1 CARTON	CREAM	1		6
53943-265-01	Freds Medicated anti itch	28 g in 1 TUBE	CREAM	28		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-265	FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [DISCOUNT DRUG MART]	6	Current NDC, Legacy NDC, 2 package rows	20231213_8697b932-da5a-717e-e053-2a91aa0afcae.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

Freds Medicated anti itch
Pramoxine hydrochloride, menthol
STEARETH-21
.ALPHA.-TOCOPHEROL ACETATE, DL-
SODIUM ACRYLATE
MINERAL OIL
EDETATE DISODIUM
EDETIC ACID
TROLAMINE
PROPYLENE GLYCOL
METHYL SALICYLATE
ALOE VERA LEAF
WATER
PETROLATUM
STEARYL ALCOHOL
PPG-1 TRIDECETH-6
EUCALYPTUS OIL
PRAMOXINE HYDROCHLORIDE
PRAMOXINE
MENTHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53943-265	53943-265-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
STEARETH-21	53J3F32P58	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT
SODIUM ACRYLATE	7C98FKB43H	IACT
MINERAL OIL	T5L8T28FGP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
TROLAMINE	9O3K93S3TK	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
PPG-1 TRIDECETH-6	1K7417JX6Q	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB
MENTHOL	L7T10EIP3A	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freds Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Discount Drug Mart	8697b932-da5a-717e-e053-2a91aa0afcae	2023-12-12	Warnings	Exact identifier ndc (package): 53943-265-01 ndc (product): 53943-265 ndc11 (package): 53943026501 spl id: 0c530ae4-9788-7809-e063-6394a90a143d spl set id: 8697b932-da5a-717e-e053-2a91aa0afcae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.