OLP BABY TEETHING- benzocaine gel

OLP Baby Teething by

Drug Labeling and Warnings

OLP Baby Teething by is a Otc medication manufactured, distributed, or labeled by Ohio Lab Pharma. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Uses

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

Warnings

• Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as

procaine, butacaine, benzocaine or other “caine” anesthetics

• Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor.
• 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 dentist or doctor.
• Stop use and ask a doctor if sore mouth symptoms do not get better in 7 days. swelling, rash or fever develops, irritation, pain or redness persists or worsens
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

anaesthetic

Active Ingredient

Benzocaine 7.5%

Other information

store at 15 to 25 C(59-77F)

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 baby teething gel
• apply to affected area up to four times daily or as directed by a dentist or doctor

for infants under 4 months of age, ask a dentist or doctor

Inactive ingredients

FD&C yellow 5, FD&C Red 40, Flavor, Glycerin, Poropylene Glycols, Purified Water, Sorbic Acid, , carbomer, methyl paraben, propyl paraben

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

• 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 contact a poison control center right away

questions

www.ohiolabpharma.us

PRINCIPAL DISPLAY PANEL

NET WEIGHT 0.33 oz (9.4g)

NDC#70648-999-01

INGREDIENTS AND APPEARANCE

OLP BABY TEETHING 
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-999
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
WATER (UNII: 059QF0KO0R)
SORBIC ACID (UNII: X045WJ989B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
CARBOMER 980 (UNII: 4Q93RCW27E)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-999-01	1 in 1 CARTON	12/06/2017
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/06/2017

Labeler - Ohio Lab Pharma (080215854)

Establishment
Name	Address	ID/FEI	Business Operations
Ohio Lab Pharma		080215854	manufacture(70648-999)