QC Medicated Anti Itch Cream

Manufacturer: Chain Drug Marketing Association | Weeks & Leo Co., Inc. | WEEKS & LEO COMPANY, INC.
Effective date: 2024-12-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:41:30

Label at a glance#

ProductQC Medicated anti itch

Active ingredientMENTHOL, PRAMOXINE HYDROCHLORIDE

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

For external use only

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

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 principal panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1116155	menthol 1 % / pramoxine HCl 1 % Topical Cream	PSN	2
1116155	menthol 10 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	2
1116155	menthol 1 % / pramoxine hydrochloride 1 % Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-959-01	QC Medicated anti itch	1 in 1 CARTON	CREAM	1		2
63868-959-01	QC Medicated anti itch	28 g in 1 TUBE	CREAM	28		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-959	QC MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	2	Current NDC, Legacy NDC, 2 package rows	20241210_b5e41e3a-81df-3a63-e053-2a95a90a5839.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-959-01	GM - Gram	63868-959	a2292b26-9014-4510-a2a5-42f34bab2bfc	1	2023-08-08

Products#

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

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

QC Medicated anti itch
Pramoxine hydrochloride, menthol
WATER
DIAZOLIDINYL UREA
TROLAMINE
STEARETH-21
PETROLATUM
METHYLPARABEN
PROPYLPARABEN
SODIUM POLYACRYLATE (8000 MW)
PROPYLENE GLYCOL
METHYL SALICYLATE
MENTHOL
PRAMOXINE HYDROCHLORIDE
PRAMOXINE
EDETATE DISODIUM
ALOE VERA LEAF
STEARYL ALCOHOL
EUCALYPTUS OIL
.ALPHA.-TOCOPHEROL ACETATE, DL-

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-959	63868-959-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	IACT
TROLAMINE	9O3K93S3TK	IACT
STEARETH-21	53J3F32P58	IACT
PETROLATUM	4T6H12BN9U	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
MENTHOL	L7T10EIP3A	ACTIB
PRAMOXINE HYDROCHLORIDE	88AYB867L5	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
EUCALYPTUS OIL	2R04ONI662	IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-	WR1WPI7EW8	IACT

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
QC Medicated anti itch	PRAMOXINE HYDROCHLORIDE, MENTHOL	Chain Drug Marketing Association	b5e41e3a-81df-3a63-e053-2a95a90a5839	2024-12-08	Warnings	Exact identifier ndc (package): 63868-959-01 ndc (product): 63868-959 ndc11 (package): 63868095901 spl id: 28cd0b68-0d27-bc7b-e063-6294a90a53a1 spl set id: b5e41e3a-81df-3a63-e053-2a95a90a5839

Reported adverse events (FAERS/openFDA)#

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