BUDPAK MEDICATED ANTI ITCH- camphor (synthetic) and menthol 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

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:

Warnings

For external use only

Do not use on children under 2 years of age.

Stop use and ask a doctor

Keep out of reach of children.

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

Directions

Other information

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
Document Id: 05ece84a-9c76-4fa6-a92c-85bcdf79546d
Set id: 6e39d14a-fee5-42d5-9b34-83d3f3951437
Version: 2
Effective Time: 20130106
 
Budpak Inc.