BUDPAK FEMININE ANTI-ITCH- benzocaine and resorcinol cream

Budpak Feminine Anti-Itch by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Benzocaine 5%

Resorcinol 2%

PURPOSE

Purpose

External analgesic

INDICATIONS & USAGE

Uses

• temporarily relieves itching

WARNINGS

Warnings

For external use only

Avoid contact with eyes

STOP USE

Stop use and ask a doctor if condition worsens or if symptoms 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

Adults and children, 2 years and older:

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

Children under 2 years of age: Consult a doctor

SPL UNCLASSIFIED SECTION

Other information

• Store at room temperature 15°C to 30°C (59°F to 86°F).
• Lot No. Exp. Date: see crimp of the tube.

INACTIVE INGREDIENT

Inactive Ingredients

Purified water, cetyl alcohol, glyceryl stearate, PEG-100 stearate, mineral oil, isopropyl palmitate, aloe barbadensis leaf juice, alpha tocopherol acetate, corn oil, cholecalciferol, methyl paraben, isopropyl myristate, sodium sulfite, trolamine, trisodium HEDTA, vitamin A palmitate, carbomer homopolymer type c.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Feminine Anti-Itch Cream

Benzocaine 5%

Resorcinol 2%

External analgesic

NET WT 0.75 OZ (21.2 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK FEMININE ANTI-ITCH 
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.05 g  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CORN OIL (UNII: 8470G57WFM)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
METHYLPARABEN (UNII: A2I8C7HI9T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM SULFITE (UNII: VTK01UQK3G)
TROLAMINE (UNII: 9O3K93S3TK)
TRISODIUM HEDTA (UNII: K3E0U7O8KI)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-022-01	1 in 1 BOX
1	NDC: 27293-022-21	21.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/10/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-022)