Active Ingredients
LIDOCAINE 4%
MENTHOL 1%
Acolye Lidocaine Cream Topical Analgesia Cream
FDA Label NDC 83566-617
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Aimu Biological Technology Co., Ltd for the product Acolye Lidocaine Cream Topical Analgesia Cream (NDC 83566-617). 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 active ingredients, purpose, uses, warnings, stop use and ask a doctor if:, do not use, when using this product, 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
Purpose
Topical analgesia
Uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
For the temporary relief of itching associated with fever blisters and cold sores.
Warnings
For external use only.
Stop Use And Ask A Doctor If:
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Do Not Use
- on wounds or damaged skin.
- on large areas of the body.
- longer than 1 week unless directed by a doctor.
-Do not use in large quantities, particularly over raw surfaces or blistered areas.
When Using This Product
- Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
- Do not use with heating pads or heat lamps.
- Discontinue use if skin irritation develops.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older:
- Clean affected area with mild soap and warm water, if needed.
- Apply a thin layer to the affected area not more than 3 to 4 times daily.
- Gently massage until absorbed.
If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: Do not use. Ask a doctor.
Inactive Ingredients
Butyrospermum Parkii (Shea Butter) ,Cocos Nucifera (Coconut) Oil,Macadamia Ternifolia Seed Oil ,Cera Alba,Simmondsia Chinensis (Jojoba) Seed Oil,Prunus Amygdalus Dulcis (Sweet Almond) Oil,Tocopheryl Acetate,Ceramide 2,Bisabolol
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