BUDPACK FEMININE ANTI-ITCH- benzocaine benzalkonium chloride cream

Budpack by

Drug Labeling and Warnings

Budpack by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Benzocaine 5%

Benzalkonium Chloride .13%

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 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 of age 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

INACTIVE INGREDIENT

Inactive Ingredients Purified water, Peg-400, Cetearyl Alcohol, Paraffinum Liquidum, Hydroxpropyl Bisstearyldimonium Chloride, Dimethicone, Glyceryl Stearate & Peg-100 Stearate, Diaziolidinyl Urea, Methyparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

 Package Label

INGREDIENTS AND APPEARANCE

BUDPACK  FEMININE ANTI-ITCH
benzocaine benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-020
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-020-01	1 in 1 BOX
1	NDC: 27293-020-21	21 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/21/2012

Labeler - Budpak Inc. (183224849)

Establishment
Name	Address	ID/FEI	Business Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture