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Budpak Medicated Anti Itch

Dosage form: cream
Ingredients: CAMPHOR (SYNTHETIC) 0.01g in 1g, MENTHOL 0.01g in 1g
Labeler: Budpak Inc.
NDC Code: 27293-027

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

Camphor 1%
Menthol 1%

Purpose

External anti-infective and anesthetic

Anti itch pain relief

Uses

For the temporary relief of pain and itching associated with:

  • minor skin irritation
  • allergic itches
  • rashes
  • hives
  • minor burns
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac

Warnings

For external use only

Do not use on children under 2 years of age.

  • avoid contact with eyes
  • do not apply to open wound or damaged skin.

Stop use and ask a doctor

  • if condition worsens
  • symptoms persist for 7 days or clear up and occur again within a few days.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

  • For children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

  • For children under 2 years of age: consult a physician.

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, Petrolatum, Cetearyl Alcohol, Glycerin, Mineral Oil, Steareth-21, Glyceryl Stearate, Steareth-2, Alcohol, Carbomer, Triethanolamine, Methylparaben, Propylparaben, Aloe barbadensis leaf juice, Vitamin E.

PRINCIPAL DISPLAY PANEL

Budpak Medicated Anti-Itch Cream

Camphor 1%

Menthol 1%

NET WT 1 OZ (28 g)

BUDPAK MEDICATED ANTI ITCH 
camphor and menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27293-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.01 g  in 1 g
MENTHOL (MENTHOL) MENTHOL0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PETROLATUM 
CETOSTEARYL ALCOHOL 
GLYCERIN 
MINERAL OIL 
STEARETH-21 
GLYCERYL MONOSTEARATE 
STEARETH-2 
ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
TROLAMINE 
METHYLPARABEN 
PROPYLPARABEN 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:27293-027-011 TUBE in 1 BOX
1NDC:27293-027-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-027)

Revised: 01/2013
 
Budpak Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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