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 Type HUMAN OTC DRUG Item Code (Source) NDC:27293-027
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.01 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.01 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARETH-21 (UNII: 53J3F32P58)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARETH-2 (UNII: V56DFE46J5)  
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:27293-027-01 1 in 1 BOX
1 NDC:27293-027-28 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/17/2012
Labeler - Budpak Inc. (183224849)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
Name Address ID/FEI Business Operations
Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(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.