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Drug Facts
Alocane Plus Gel
FDA Label NDC 68229-300
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 Plus (NDC 68229-300). 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 - keep out of reach of children, otc - stop use, otc - pregnancy or breast feeding, directions, 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 of the skin. Temporarily relieves pain and itching due to:
- Minor Burns
- Minor Cuts & Scrapes
- Minor Skin Irritations
Warnings
For external use only. Avoid contact with eyes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical help or call a Poison Control Center right away.
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.
Directions
Adults and children 2 years of age and older: Apply to affected areas not more than 3 to 4 times daily.
Children under 2 years of age: consult a doctor.
Other Information
Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.
Principal Display Panel - 48 Packet Carton
Pdp (68229 300 06)
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