BUDPAK FIRST AID- lidocaine hcl and phenol cream

Budpak First Aid by

Drug Labeling and Warnings

Budpak First Aid 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

Lidocaine HCl 0.5%

Phenol 0.5%

PURPOSE

Purpose

Topical Anesthetic

Antiseptic

INDICATIONS & USAGE

Uses

• first aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

STOP USE

Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases or if infection develops.

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

• Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. May be covered with sterile bandage.

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, Mineral Oil, Petrolatum, Cetearyl Alcohol, Glyceryl Stearate, Propylene Glycol, Stearic Acid, Methylparaben, Sorbitan Stearate,  Polysorbate 60, Propylparaben, .

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

Budpak First Aid Cream

Lidocaine HCl 0.5%

Phenol 0.5%

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK FIRST AID 
lidocaine hcl and phenol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.005 g  in 1 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	0.005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-016-01	1 in 1 BOX
1	NDC: 27293-016-28	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	06/12/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-016)