Your browser does not support JavaScript! BUDPAK MEDICATED ANTI ITCH (CAMPHOR AND MENTHOL) CREAM [BUDPAK INC. ]
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BUDPAK MEDICATED ANTI ITCH (camphor and menthol) cream
[Budpak Inc. ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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)

image of package label

BUDPAK MEDICATED ANTI ITCH 
camphor and menthol cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:27293-027-011 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/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(27293-027)

Revised: 1/2013
 
Budpak Inc.

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