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Drug Facts
Alocane Max Gel
FDA Label NDC 68229-406
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quest Products Llc for the product Alocane Max (NDC 68229-406). 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 other, otc - purpose, uses:, warnings, otc - ask doctor, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredient | Purpose |
|---|---|
Benzalkonium Chloride 0.13% Lidocaine HCL 4% | First Aid Antiseptic Topical Analgesic |
Uses:
First aid to help prevent bacterial infection associated with contamination or skin infection, and for the temporary relief of pain and itching associated with minor: :
- Burns
- Cuts
- Sunburn
- Scrapes
- Minor Skin Irritations
Warnings
For external use only.
Otc - Ask Doctor
Ask a doctor before use if you have:
- Deep or puncture wounds
- Animal bites
- Serious burns
Otc - Do Not Use
Do not use:
- In or near the eyes
- In large quantities or over large areas of the body
- On raw surfaces or blistered areas
Otc - Stop Use
Stop use and ask doctor: If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.
Directions:
Adults and children 2 years of age and older: Clean the affected area. Apply a small amounbt of gel on the affected area not more than 3 to 4 times daily. May be covered with a sterile bandgae (let dry first).
Children under 2 years of age: ask a doctor.
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Propanediol, Tocopheryl Acetate (Vitamin E), Water.
Principal Display Panel - 2.5 Fl Oz Tube
2oztube (406 02pdp)
24 Count Single Use
24sachet (406 07pdp)
* Please review the disclaimer below.
