ANTI-ITCH REGULAR STRENGTH- benzocaine and resorcinol cream

Anti-Itch by

Drug Labeling and Warnings

Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Walgreens, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzocaine 5%

Resorcinol 2%

Purpose

External Analgesic

External Analgesic

Use

Temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

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.

Do not apply over large areas of the body.

Do not use if allergic to any of the ingredients

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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.
• clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.

children under 12 years

• consult a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium  HEDTA, water

Questions or comments

1-800-WALGREEN (1-800-925-4733)

Principal display panel - 28 g Carton Label

NDC: 0363-0621-02

REGULAR STRENGTH

Anti-Itch Cream

Pain Relieving Cream

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ANTI-ITCH   REGULAR STRENGTH
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0621
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	5 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM SULFITE (UNII: VTK01UQK3G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0621-02	1 in 1 CARTON	01/09/2020
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/09/2020

Labeler - Walgreens (008965063)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(0363-0621)