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NDC 00363-0674-64 Well at Walgreens Anti-Itch 20; 3 g/100g; g/100g Details

Well at Walgreens Anti-Itch 20; 3 g/100g; g/100g

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

Product Information

NDC	00363-0674
Product ID	0363-0674_d6dd7194-15f7-20af-e053-2995a90ad54a
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	Well at Walgreens Anti-Itch
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Benzocaine and Resorcinol
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	20; 3
Active Ingredient Units	g/100g; g/100g
Substance Name	BENZOCAINE; RESORCINOL
Labeler Name	Walgreens
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00363-0674-64 (00363067464)

Pricing Information	N/A
NDC Package Code	0363-0674-64
Billing NDC	00363067464
Package	28 g in 1 TUBE (0363-0674-64)
Marketing Start Date	2016-07-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0dcc6808-2326-429b-96b0-35f29a89486c Details

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

Use

Temporarily relieves itching

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Also, do not use if you have an unusual or abnormal vaginal discharge except under the supervision of a physician.

Do not apply over large areas of the body.

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 fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily

children under 12 years

consult a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, carbomer, cetyl alcohol, corn oil, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E & D

Principal display panel - 28 g Carton Label

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

NEW

MAXIMUM STRENGTH

Anti-Itch Cream

Pain Relieving Cream

Instantly soothes & relieves external itching & burning
Soothes irritated skin with aloe
Helps prevent further irritation
Fresh, clean scent

Compared to Vaglsil® Maximum Strength active ingredients‡‡

Relieves vaginal itching.

NDC 0363-0674-64

Well at Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

MAXIMUM STRENGTH

Anti-Itch Cream

Pain Relieving Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

WELL AT WALGREENS ANTI-ITCH MAXIMUM STRENGTH

benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0674
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CORN OIL (UNII: 8470G57WFM)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0674-64	28 g in 1 TUBE; Type 0: Not a Combination Product	07/27/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	07/27/2016

Labeler - Walgreens (008965063)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Name	Address	ID/FEI	Business Operations
Establishment
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(0363-0674)

Revised: 1/2022

Document Id: d6dd7194-15f7-20af-e053-2995a90ad54a

Set id: 0dcc6808-2326-429b-96b0-35f29a89486c

Version: 2

Effective Time: 20220131