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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