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Budpak First Aid

Medically reviewed on June 12, 2018

Dosage form: cream
Ingredients: LIDOCAINE HYDROCHLORIDE 0.005g in 1g, PHENOL 0.005g in 1g
Labeler: Budpak Inc.
NDC Code: 27293-016

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.

Active Ingredients

Lidocaine HCl 0.5%

Phenol 0.5%

Purpose

Topical Anesthetic

Antiseptic

Uses

  • first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

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

  • Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with sterile bandage.

Other Information

  • Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF).
  • Lot No. & Exp. Date: see crimp of tube.

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)

BUDPAK FIRST AID 
lidocaine hcl and phenol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-016
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.005 g  in 1 g
PHENOL (PHENOL) PHENOL0.005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
PETROLATUM 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
STEARIC ACID 
METHYLPARABEN 
SORBITAN MONOSTEARATE 
POLYSORBATE 60 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:27293-016-011 TUBE 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/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-016)

 
Budpak Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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