Otc - Active Ingredient
Active ingredient:
- Lidocaine HCl 4%
- Menthol 1%
The following Structured Product Label (SPL) was submitted to the FDA by Dr.johnes Llc for the product Dr.johnes Lidocaine 4% Topical Analgesic Cream (NDC 85818-007). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient:
Purpose: Topical Analgesic
Uses: For temporary relief of minor aches and pains of muscles and joints associated with:
For external use only
Do not use:
When using this product:
Stop use and ask a doctor if:
If pregnant or breast-feeding
Ask a health professional before use
Keep out of reach of children.
If swallowed, get medical help or contact Poison Control immediately.
Directions:
Inactive ingredients:
The difference in ingredient naming between the SPL submission and the product packaging is due to differences in regulatory nomenclature and consumer-facing labeling conventions. The SPL uses standardized pharmaceutical ingredient names required for regulatory identification and electronic drug listing purposes, while the product packaging uses simplified or common names intended for consumer readability. Both representations refer to the same formulation and identical active and inactive ingredients, with no differences in strength, dosage form, or composition of the finished drug product. Any variation in terminology (e.g., INCI/common names vs. pharmacopoeial names) is solely for labeling clarity and does not reflect any difference in product identity or formulation. All naming differences are non-substantive and do not affect regulatory identity.
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