BUDPAK MEDICATED ANTI ITCH- camphor and menthol cream

Budpak Medicated Anti Itch by

Drug Labeling and Warnings

Budpak Medicated Anti Itch by is a Otc medication manufactured, distributed, or labeled by Budpak Inc. , Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Camphor 1%
Menthol 1%

PURPOSE

Purpose

External anti-infective and anesthetic

Anti itch pain relief

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

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

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

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.

SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT

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.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak Medicated Anti-Itch Cream

Camphor 1%

Menthol 1%

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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)