BUDPAK BABY TEETHING ORAL PAIN RELIEVER- benzocaine gel

Budpak Baby Teething Oral Pain Reliever by

Drug Labeling and Warnings

Budpak Baby Teething Oral Pain Reliever 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

Benzocaine 7.5%

PURPOSE

Purpose

Oral pain reliever

INDICATIONS & USAGE

Use

temporarily relieves sore gums due to teething in infants and children 4 months and older

WARNINGS

Warnings

Allergy alert: do not use this product if your baby has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

DO NOT USE

Do not use

• for more than 7 days unless told to do so by a physician
• more than directed

WHEN USING

When using this product

• fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your physician.

STOP USE

Stop using and ask a dentist or physician if

• sore mouth symptoms do not get better in 7 days
• irritation, pain or redness does not go away
• swelling, rash or fever develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In cases of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Directions

• do not use if tube safety seal is broken
• wash hands
• break seal on tube
• use your fingertip or cotton applicator to apply a small pea-size amount of Budpak Baby Teething Gel Medicine.
• apply to affected area up to 4 times daily or as directed by a dentist or physician.
• for infants under 4 months of age, ask a doctor

SPL UNCLASSIFIED SECTION

Other information

• Store at 15°C to 25 °C (59°F to 77°F)
• Lot No. & Exp. Date: see crimp of tube

INACTIVE INGREDIENT

Inactive Ingredients

Glycyrrhizin Ammoniated, Glycerin, Polyethylene glycol, Purified water, Sodium saccharin, Sorbic acid, Sorbitol, Flavor, Red #40.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

BUDPAK BABY TEETHING PAIN RELIEVER GEL

Benzocaine 7.5%

NET WT 0.5 OZ. (14 g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUDPAK BABY TEETHING ORAL PAIN RELIEVER 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-015-01	1 in 1 BOX
1	NDC: 27293-015-14	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/26/2013

Labeler - Budpak Inc. (183224849)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(27293-015)