OUTGRO- benzocaine liquid 
Medtech Products 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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Outgro

Outgro®

PAIN RELIEVING LIQUID

Drug Facts

Active Ingredient

Benzocaine 20% w/v

Purpose

Topical analgesic

Use

For the temporary relief of pain associated with minor skin irritations.

Warnings

For external use only.

■ Extremely Flammable. Keep away from fire or flame. Avoid smoking during use and until product has dried.

When using this product:

avoid contact with eyes.

Stop use and ask a doctor if:

■ condition worsens ■ condition does not improve in 7 days ■ condition clears up and occurs again within a few days.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and olderUsing applicator, apply to affected area not more than 3 to 4 times daily
Children under 2 years of ageConsult a doctor

Other Information

■ store at room temperature away from heat.

Inactive Ingredients

Alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, PEG-8

Questions?

1-800-443-4908

Principal Display Panel

Outgro
BENZOCANE
PAIN RELIEVING
LIQUID
.31 FL OZ/ 9 mL

Outgro
BENZOCANE
PAIN RELIEVING
LIQUID
.31 FL OZ/ 9 mL

OUTGRO 
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-531
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE18.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-531-111 in 1 BOX01/01/2013
19 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/01/2013
Labeler - Medtech Products Inc. (122715688)

Revised: 10/2017
Document Id: 9eda3ff1-260d-4242-a5a2-bdee8a7e98bf
Set id: d6be8a1d-aca7-42b1-86da-881d42ffe8d5
Version: 4
Effective Time: 20171002
 
Medtech Products Inc.