Sign In

Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"

You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.

View Generic:
View Brand:

Outgro - Medication Information

Product NDC Code 63029-531
Drug Name

Outgro

Type Brand
Pharm Class Allergens [CS],
Cell-mediated Immunity [PE],
Increased Histamine Release [PE],
Standardized Chemical Allergen [EPC]
Active Ingredients
Benzocaine 18.6 g/100ml
Route TOPICAL
Dosage Form LIQUID
Application Number part348
Labeler Name Medtech Products Inc.
Packages
Package NDC Code Description
63029-531-11 1 bottle, with applicator in 1 box (63029-531-11) / 9 ml in 1 bottle, with applicator
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Benzocaine 20% w/v

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive I ngredients Alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Red #40, PEG-8 Questions? 1-800-443-4908

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use For the temporary relief of pain associated with minor skin irritations.

Purpose

Information about the drug product’s indications for use.
Purpose Topical analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Outgro Benzocaine BENZOCAINE BENZOCAINE ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 POLYETHYLENE GLYCOL 400

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Outgro BENZOCANE PAIN RELIEVING LIQUID .31 FL OZ/ 9 mL Outgro BENZOCANE PAIN RELIEVING LIQUID .31 FL OZ/ 9 mL

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Outgro® PAIN RELIEVING LIQUID Drug Facts Other I nformation ■ store at room temperature away from heat.

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-800-443-4908

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product: avoid contact with eyes.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API