FDA Label for 2677 First Aid Burn Cream
View Indications, Usage & Precautions
2677 First Aid Burn Cream Product Label
The following document was submitted to the FDA by the labeler of this product Prostat First Aid Llc. 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 Ingredient
Lidocaine Hydrochloride 0.5%
Benzalkonium Chloride 0.13%
Purpose
Topical Analgesic
Topical Antiseptic
Use(S)
For temporary relief of pain and itching associated with:
• Sunburn • Minor burns • Insect bites • Cuts • Scrapes
Warnings
For External Use Only
Do Not Use
• In the eyes • Over large areas of the body or on deep puncture wounds, animal bites, or serious burns • In large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
• The condition gets worse • Condition clears up and recurs within a few days • Condition persists for more than 7 days
If Pregnant Or Breast Feeding
Ask a healthcare professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and children 2 years and older:
• Clean the affected area • Apply a small amount of this product on the area 3 to 4 times daily • May be covered with a sterile bandage
Children under 2 years: • Consult a doctor
Other Information
• Store in a cool, dry area 15°-25° C (59°-77° F)
• Tamper evident sealed packets
• Do not use any opened or torn packets
Inactive Ingredients
Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben
Questions?
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Label
PROSTAT First Aid Burn Cream
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