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NDC 00363-2311-28 Anti-Itch Medicated Maximum Strength 200; 30 mg/g; mg/g Details

Anti-Itch Medicated Maximum Strength 200; 30 mg/g; mg/g

Anti-Itch Medicated Maximum Strength is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens Company. The primary component is BENZOCAINE; RESORCINOL.

Product Information

NDC	00363-2311
Product ID	0363-2311_877ce040-c6d7-4d61-97f2-4ddf0a5094a9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Anti-Itch Medicated Maximum Strength
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzocaine and Resorcinol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	200; 30
Active Ingredient Units	mg/g; mg/g
Substance Name	BENZOCAINE; RESORCINOL
Labeler Name	Walgreens Company
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-2311-28 (00363231128)

Pricing Information	N/A
NDC Package Code	0363-2311-28
Billing NDC	00363231128
Package	1 TUBE in 1 CARTON (0363-2311-28) / 28 g in 1 TUBE
Marketing Start Date	2018-07-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7fd86dcb-edef-4d0d-b389-7ecea595fe67 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzocaine 20%

Resorcinol 3%

Purpose

External analgesic

Use

temporarily relieves itching

Warnings

For external use only

Allergy Allert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.

Avoid contact with eyes

in case of contact rinse thoroughly and immediately with water.

Stop use and ask doctor if

condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Keep out of reach of children.

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

Directions

Adults and children 12 years and older

Apply a finger tip amount (approxiamtely a 1 inch strip) to the affected areas not more than 3 to 4 times daily

Children under 12 years

ask a doctor

Other Information:

questions?

Inactive ingredients

Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium EDTA, Maltodextrin

Principal Display Panel- Tube

Walgreens NDC 0363-2311-28

Maximum Strength Anti-Itch Creme

Benzocaine 20% External Analgesic

Resorcinol 3% External Analgesic

NET WT 1 oz. (28 g)

Principal Display Panel- Carton

Walgreens NDC 0363-2311-28

MAXIMUM STRENGTH ANTI ITCH CREAM

Benzocaine 20% External Analgesic

Resorcinol 3% External Analgesic

NET WT 1.0 OZ (28g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH MEDICATED MAXIMUM STRENGTH

benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-2311
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	30 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
SODIUM SULFITE (UNII: VTK01UQK3G)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-2311-28	1 in 1 CARTON	07/19/2018
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	07/16/2018

Labeler - Walgreens Company (008965063)

Revised: 10/2021

Document Id: 877ce040-c6d7-4d61-97f2-4ddf0a5094a9

Set id: 7fd86dcb-edef-4d0d-b389-7ecea595fe67

Version: 1

Effective Time: 20211008