OLP BABY TEETHING- benzocaine gel 
Ohio Lab Pharma

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Uses

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

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

keep out of reach of children

in case of overdose or allergic reaction contact a poison control center right away

questions

www.ohiolabpharma.us

NET WEIGHT 0.33 oz (9.4g)

NDC#70648-999-01

olp baby teething gel

OLP BABY TEETHING 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70648-999
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70648-999-011 in 1 CARTON12/06/2017
19.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/06/2017
Labeler - Ohio Lab Pharma (080215854)
Establishment
NameAddressID/FEIBusiness Operations
Ohio Lab Pharma080215854manufacture(70648-999)

Revised: 4/2020
Document Id: 7b9ba87e-0224-c428-e053-2a91aa0a1277
Set id: 5fb4a35b-4567-020e-e053-2991aa0a8b29
Version: 2
Effective Time: 20200401
 
Ohio Lab Pharma