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Drug Facts
Alocane Botanicals Spray
FDA Label NDC 68229-405
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 Botanicals (NDC 68229-405). 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, active ingredient, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Lidocaine HCL 4%
Purpose
Topical Pain Relief
Uses
For the temporary relief of pain and itching associated with:
- Sunburn
- Minor Skin Irritation
- Minor Burns
- Minor Cuts & Scrapes
- Insect Bites
Warnings
For external use only. Avoid contact with eyes.
Otc - Do Not Use
Do not use:
- in large quantities, or over large areas of the body
- Over raw surfaces or blistered areas
- If you have an allergy to any of the ingredients
Otc - Ask Doctor
Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin
Otc - Stop Use
Stop use and ask doctor:
- if condition worsens
- if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 or older:
Shake well. Apply top affected area not more than 3-4 times daily. To apply to face, spray on palm and carefully apply.
Children under 2 years of age, ask a doctor before use.
Other Information
Store at 15-30°C (59-86°F)
Inactive Ingredients
Water, Phenoxyethanol, Aloe Vera Leaf Juice, Lactobacilus Ferment, Echinacea Purpurea Root Extract, Calendula Officinalis Flower Extract, Sodium Hyaluronate, D-Panthenol, Glycerin, Hydroxyethyl Cellulose, Mannitol, Sodium Hydroxide
Principal Display Panel -- Alocane Botanicals 4Oz Spray Bottle
Pdp4oz (Pdp.405.01)
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