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Alocane botanicals - Medication Information

Product NDC Code 68229-405
Drug Name

Alocane botanicals

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride 4 g/100ml
Route TOPICAL
Dosage Form SPRAY
RxCUI drug identifier 1045432,
2464334
Application Number part348
Labeler Name Quest Products, LLC.
Packages
Package NDC Code Description
68229-405-01 118 ml in 1 bottle, spray (68229-405-01)
68229-405-02 104 ml in 1 bottle, spray (68229-405-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Lidocaine HCL 4%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For the temporary relief of pain and itching associated with: Sunburn Minor Skin Irritation Minor Burns Minor Cuts & Scrapes Insect Bites

Purpose

Information about the drug product’s indications for use.
Purpose Topical Pain Relief

Spl product data elements

Usually a list of ingredients in a drug product.
Alocane Botanicals Lidocaine Hydrochloride MANNITOL SODIUM HYDROXIDE LIMOSILACTOBACILLUS FERMENTUM HYALURONATE SODIUM GLYCERIN ECHINACEA PURPUREA ROOT ALOE VERA LEAF HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) PHENOXYETHANOL WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS CALENDULA OFFICINALIS FLOWER DEXPANTHENOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL -- Alocane Botanicals 4oz Spray Bottle PDP4oz

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
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

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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.

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding , ask a health care professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store at 15-30°C (59-86°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only. Avoid contact with eyes. 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 Ask a doctor before use if you have a severe burn or deep cut, broken or compromised skin 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a health care professional before use.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API