MY FAIR BABY INSTANT PAIN RELIEF- benzocaine gel 
Delta Brands Inc

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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Drug Facts

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 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 case of overdose or allergic reaction get medical help or contact a Poison Control Center right away

Directions

■ wash your hands ■ use your fingertip or cotton applicator to apply a small pea-size amount of Oral Gel and spread over gums ■ apply to affected area up to 4 times daily or as directed by a physician or healthcare provider ■ for children under 2 years of age, consult a physician or health care provider

Other information

do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, red 40, sodium saccharin

Package Label

image description

MY FAIR BABY  INSTANT PAIN RELIEF
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-560
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
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GELATIN (UNII: 2G86QN327L)  
MINERAL OIL (UNII: T5L8T28FGP)  
PECTIN (UNII: 89NA02M4RX)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:20276-560-011 in 1 BOX
1NDC:20276-560-1414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/2014
Labeler - Delta Brands Inc (102672008)

Revised: 6/2014
Document Id: 00e02dfa-892d-4095-bcee-a3dd2bca05f5
Set id: 8b48d56c-7658-48ac-ab92-88d4c1fa14ec
Version: 1
Effective Time: 20140627
 
Delta Brands Inc