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NDC 63868-0959-01 QC Medicated anti itch 1; 1 g/100g; g/100g Details

QC Medicated anti itch 1; 1 g/100g; g/100g

QC Medicated anti itch is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is MENTHOL; PRAMOXINE HYDROCHLORIDE.

Product Information

NDC	63868-0959
Product ID	63868-959_b5e41e3a-81e0-3a63-e053-2a95a90a5839
Associated GPIs
GCN Sequence Number	042138
GCN Sequence Number Description	pramoxine HCl/menthol CREAM (G) 1 %-1 % TOPICAL
HIC3	L3P
HIC3 Description	ANTIPRURITICS,TOPICAL
GCN	93510
HICL Sequence Number	005867
HICL Sequence Number Description	PRAMOXINE HCL/MENTHOL
Brand/Generic	Generic
Proprietary Name	QC Medicated anti itch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pramoxine hydrochloride, menthol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	1; 1
Active Ingredient Units	g/100g; g/100g
Substance Name	MENTHOL; PRAMOXINE HYDROCHLORIDE
Labeler Name	Chain Drug Marketing Association
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0959-01 (63868095901)

Pricing Information	N/A
NDC Package Code	63868-959-01
Billing NDC	63868095901
Package	1 TUBE in 1 CARTON (63868-959-01) / 28 g in 1 TUBE
Marketing Start Date	2020-12-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b5e41e3a-81df-3a63-e053-2a95a90a5839 Details

Active Ingredient

Menthol 1%

Pramoxine hydrochloride 1%

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

Purpose

Topical anagesic

Warnings

When using this product

do not get into eyes

Keep out of reach of children

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

Other Information

store at controlled room temperature

Directions

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

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

Inactive Ingredients

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

INGREDIENTS AND APPEARANCE

QC MEDICATED ANTI ITCH

pramoxine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-959
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g in 100 g

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-959-01	1 in 1 CARTON	12/07/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/07/2020

Labeler - Chain Drug Marketing Association (011920774)

Registrant - Weeks & Leo Co., Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
WEEKS & LEO COMPANY, INC.		005290028	manufacture(63868-959)

Revised: 12/2020

Document Id: b5e41e3a-81e0-3a63-e053-2a95a90a5839

Set id: b5e41e3a-81df-3a63-e053-2a95a90a5839

Version: 1

Effective Time: 20201207