Otc - Active Ingredient
Lidocaine HCl 4%
Menthol 1%
Dzul - Lido Creme Lotion
FDA Label NDC 83037-041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Caball Sales, Inc. for the product Dzul - Lido Creme (NDC 83037-041). 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 otc - active ingredient, otc - purpose, uses:, warnings, otc - when using, stop use and ask a doctor if:, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Uses:
For temporary local relief of minor pain in muscles or joints.
Warnings
For external use only.
Ask a doctor before use if you have redness over affected area.
Otc - When Using
Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or use with a heating pad.
A transient burning sensation or redness may occur upon application but generally disappears in several days.
Do not apply on large areas of the body or on damaged, broken, or irritated skin.
Stop Use And Ask A Doctor If:
Redness is present.
Condition worsens.
Irritation develops.
Symptoms persist for more than 7 days or clear up and occur again within a few days.
You experience signs injury, such as pain, swelling or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children over 12 years of age
Apply a small amount to the affected area.
Massage in a circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Children under 12 years of age; do not use unless directed by doctor.
Other Safety Information
Store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredient
Water, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glycol Stearate, Stearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Sodium Lauryl Sulfate, Dimethicone, Glycerin, Caprylhydroxamic Acid, Caprylyl Glycol, Eucalyptus Globulus Leaf Oil, Phenoxyethanol, Methylpropanediol, Acrylamide/Sodium Acrylate Copolymer, Paraffinum Liquidum, Trideceth-6, Methylsulfonylmethane, Aloe Barbadensis (Aloe Vera) Leaf Juice, Rosmarinus Officinalis (Rosemary) Oil, Tocopheryl Acetate, Arnica Montana Flower Extract, Salix Alba Bark Extract, Glucosamine Sulfate, Chamomilla Recutita (Matricaria) Flower Extract, Capsicum Annuum Fruit Extract.
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