Ambix First Aid
FDA Label NDC 10038-250

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Organics Corporation Of America Dba Ambix Laboratories for the product Ambix First Aid (NDC 10038-250). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Phenol 0.5%

Dyclonine Hydrochloride 0.5%

Purpose

First Aid Antiseptic

Topical Anesthetic

Uses

  • first aid to help protect against infection and for the temporary relief of pain and itching associated with minor burns, minor cuts, scrapes, insect bites, or minor skin irritations.

Warnings

■ For external use only ■ Do not bandage ■ Do not use in the eyes or apply over large areas of the body ■ Do not use longer than 1 week unless directed by a doctor

Otc - Do Not Use

Do not use in eyes, do not apply over large areas of the body. In case of deep puncture wounds or serious burns, consult a doctor.

Ask A Doctor Before Use If You Have

a deep or puncture wound, an animal bite, serious burn, or before using on a child aged 2 or under.

Stop Use And Ask A Doctor If

redness, irritation, swelling, or pain persists or increases.

Keep Out Of Reach Of Children

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

Directions

■ Clean the affected area ■ Apply a small amount of this product on the area 1 to 3 times daily

Other Information

  • Store at controlled room temperature 15°C to 30°C (59°F to 86°F).
  • You may report serious side effects to the phone number provided under “Questions?” below

Inactive Ingredients

Allantoin, Benzyl Alcohol, Disodium EDTA, Glyceryl Stearate, Mineral Oil, Methyl Paraben, Petrolatum, Propyl Paraben, Sodium Lauryl Sulfate, Stearic Acid, Stearyl Alcohol, Triethanolamine, Water

Package Label.Principal Display Panel


Ambix

FIRST AID

Antiseptic & Pain Relieving Cream

Net Wt. 7/8 oz. (25 grams)

Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

Ambix

FIRST AID

Antiseptic & Pain Relieving Cream

Net Wt. 1-1/2 oz. (42.5 grams)

Dist. by Ambix Laboratories, Totowa, NJ 07512 ■ Made in USA ■ © 2013

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