Budpak Baby Teething Oral Pain Reliever description, usages, side effects, indications, overdosage, supplying and lots more!

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Budpak Baby Teething Oral Pain Reliever

Budpak Inc.
Anicare Pharmaceuticals Pvt. Ltd

Budpak Baby Teething Oral Pain Reliever Gel




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient

Benzocaine 7.5%

Purpose

Purpose

Oral pain reliever

Uses

Use

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

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

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

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 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.

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

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

Other information

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

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

BUDPAK BABY TEETHING PAIN RELIEVER GEL

Benzocaine 7.5%

NET WT 0.5 OZ. (14 g)

Budpak Baby Teething Oral Pain Reliever

Budpak Baby Teething Oral Pain Reliever

Benzocaine GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:27293-015
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 7.5 g

Inactive Ingredients

Ingredient Name Strength
GLYCYRRHIZIN, AMMONIATED
GLYCERIN
POLYETHYLENE GLYCOLS
water
saccharin sodium
sorbic acid
sorbitol
FD&C RED NO. 40

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2013-12-26


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Be sure to consult your doctor before taking any medication!
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