FDA Label for Ambix First Aid

View Indications, Usage & Precautions

Ambix First Aid Product Label

The following document was submitted to the FDA by the labeler of this product Organics Corporation Of America Dba Ambix Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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