BUDPAK FEMININE ANTI-ITCH- benzocaine and resorcinol cream 
Budpak Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

Benzocaine 5%

Resorcinol 2%

Purpose

External analgesic

Uses

Warnings

For external use only

Avoid contact with eyes

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

Directions

Adults and children, 2 years and older:

Children under 2 years of age: Consult a doctor

Other information

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.

PRINCIPAL DISPLAY PANEL

Budpak Feminine Anti-Itch Cream

Benzocaine 5%

Resorcinol 2%

External analgesic

NET WT 0.75 OZ (21.2 g)

image of package label

BUDPAK FEMININE ANTI-ITCH 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.05 g  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-022-011 in 1 BOX
1NDC:27293-022-2121.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/10/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-022)

Revised: 6/2013
Document Id: 2723f378-f50f-4606-b0b4-d6b33b7eddf2
Set id: c64ec9ab-e916-4fea-9512-b2ab365e0cdc
Version: 1
Effective Time: 20130608
 
Budpak Inc.