Otc - Active Ingredient
Active Ingredient Diclofenac sodium 1% (NSAID*) Purpose Arthritis pain reliever*nonsteroidal anti-inflammatory drug
Zkbb Arthritis Pain Relief Cream
FDA Label NDC 87083-027
8 label sections · Submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd for the product Zkbb Arthritis Pain Relief (NDC 87083-027). 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, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses for the temporary relief of arthritis pain in the following areas: • hand • wrist • elbow • foot • ankle • knee
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
WARNINGS • For external use only.
Indications & Usage
• Do not use in large amounts, especially on raw surfaces or blistered areas, wounds, broken or irritated skin; or if you are allergic to any ingredient in this product. • When using this product: Avoid contact with eyes. If contact occurs, rinse thoroughly with water. • Stop use and consult a doctor if the condition worsens, symptoms persist for more than 7 days, symptoms clear up and recur within a few days, or if rash, itching, redness, swelling, irritation, or a burning sensation occurs. • If pregnant or breastfeeding, ask a health professional before use. • Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Adults and children 12 years of age and older: Apply a thin layer to the affected area. Use no more than 3 to 4 times daily. Allow the cream to dry before dressing. Wash hands after use unless treating the hands. Avoid contact with eyes and mouth. • Children under 12 years of age: Consult a doctor before use.
Inactive Ingredient
INACTIVE INGREDIENTS White Petrolatum, Mineral Oil, Glycerin, Propylene Glycol, Dimethicone, Phenoxyethanol, Wintergreen Oil, Cetearyl Alcohol, Glyceryl Stearate, Polyethylene glycol 100, Allantoin, Panthenol, Capsaicin, Disodium EDTA, Tocopheryl Acetate, Water.
Package Label.Principal Display Panel
Package (87083 027 01 50g)
* Please review the disclaimer below.
