BUDPAK FIRST AID- lidocaine hcl and phenol 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

Lidocaine HCl 0.5%

Phenol 0.5%

Purpose

Topical Anesthetic

Antiseptic

Uses

Warnings

For external use only

Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases or if infection develops.

Keep out of reach of children.

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

Directions

Other Information

Inactive Ingredients

Purified Water, Mineral Oil, Petrolatum, Cetearyl Alcohol, Glyceryl Stearate, Propylene Glycol, Stearic Acid, Methylparaben, Sorbitan Stearate,  Polysorbate 60, Propylparaben, .

PRINCIPAL DISPLAY PANEL

Budpak First Aid Cream

Lidocaine HCl 0.5%

Phenol 0.5%

NET WT 1 OZ (28 g)

image of package label

BUDPAK FIRST AID 
lidocaine hcl and phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:27293-016-011 in 1 BOX
1NDC:27293-016-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/12/2013
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-016)

Revised: 6/2013
Document Id: 7f9aefd9-47cf-49cf-a1b2-b6a2b60695ea
Set id: 40159073-39ca-4557-8478-8490fb6986ea
Version: 1
Effective Time: 20130612
 
Budpak Inc.