MAKESENSE JUNIOR PAIN RELIEF- benzocaine gel

MAKESENSE by

Drug Labeling and Warnings

MAKESENSE by is a Otc medication manufactured, distributed, or labeled by Cherry Hill Sales Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzocaine 7.5%

Purpose

Oral Pain Reliever

Uses

for the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.

Warnings

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

Do not use

■ more than directed ■ for more than 7 days unless directed by a physician or healthcare provider 

When using this product

■ fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician

Stop use and ask a dentist or doctor 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 case of overdose or allergic reaction get medical help or contact a Poison Control Center immediately.

Directions

■ wash hands ■ cut open tip of tube on score mark ■ use your fingertip or cotton applicator to apply a small pea-size amount of MakeSense Junior Teething Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a dentist or physician ■ for infants under 2 years of age, ask a doctor or health care provider

Other information

■ store at 59 to 77F (15-25C) ■ do not use if tube tip is cut prior to opening

Inactive ingredients

Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

Package Label

INGREDIENTS AND APPEARANCE

MAKESENSE  JUNIOR PAIN RELIEF
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69020-206
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
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69020-206-14	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	07/15/2014

Labeler - Cherry Hill Sales Co (145959768)