BUDPAK ANTI-ITCH- hydrocortisone cream

BudPak Anti-Itch by

Drug Labeling and Warnings

BudPak 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 Ingredient

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

for the temporary relief of itching associated with minor skin irritations and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital, feminine and anal itching

Other uses or the use of the product for more than 7 days should be undertaken only under the advice and supervision of a doctor.

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Ask a doctor.

WHEN USING

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

for itching of skin irritation, inflammation, and rashes:

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years: Ask a doctor

for external anal and genital itching, adults:

• when practical, clean the affected area with mild soap and water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

• Store at room temperature
• Lot No. & Exp. Date:see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

Purified Water, Mineral Oil, Propylene Glycol, Cetearyl Alcohol, Petrolatum, Glyceryl Stearate, Polysorbate 60, Sorbitan Stearate, Methylparaben, Propylparaben, Disodium Edta

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

BUDPAK ANTI-ITCH CREAM

Hydrocortisone 1%

NET WT 0.5 OZ. (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-017-01	1 in 1 BOX
1	NDC: 27293-017-14	14 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(27293-017)