outgro

outgro
SPL v5
SPL
SPL Set ID d6be8a1d-aca7-42b1-86da-881d42ffe8d5
Route
topical
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (18.6 g)
Inactive Ingredients
alcohol d&c yellow no. 10 fd&c blue no. 1 fd&c red no. 40 polyethylene glycol 400

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2013-01-01

Purpose

Topical analgesic

Description

Outgro® PAIN RELIEVING LIQUID Drug Facts


Medication Information

Warnings

For external use only.

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

Purpose

Topical analgesic

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
Description

Outgro® PAIN RELIEVING LIQUID Drug Facts

Principal Display Panel

Outgro

BENZOCAINE

PAIN RELIEVING

LIQUID

.31 FL OZ/ 9 mL

Questions?

1-800-443-4908

Use

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

Other

■ store at room temperature away from heat.

Section 42229-5

Outgro®

PAIN RELIEVING LIQUID

Drug Facts

Inactive

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

Active Ingredient

Benzocaine 20% w/v

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.


Structured Label Content

Warnings

For external use only.

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

Purpose

Topical analgesic

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
Principal Display Panel

Outgro

BENZOCAINE

PAIN RELIEVING

LIQUID

.31 FL OZ/ 9 mL

Questions?

1-800-443-4908

Use

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

Other

■ store at room temperature away from heat.

Section 42229-5 (42229-5)

Outgro®

PAIN RELIEVING LIQUID

Drug Facts

Inactive

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

Active Ingredient

Benzocaine 20% w/v

When Using This Product: (When using this product:)

avoid contact with eyes.

Stop Use and Ask A Doctor If: (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. (Keep out of the reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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