OUTGRO- benzocaine liquid

Outgro by

Drug Labeling and Warnings

Outgro by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 older: Using applicator, apply to affected area not more than 3 to 4 times daily
• Children under 2 years of age: Consult 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

INGREDIENTS AND APPEARANCE

OUTGRO 
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-531
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	18.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-531-11	1 in 1 BOX	01/01/2013
1		9 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/01/2013

Labeler - Medtech Products Inc. (122715688)