FDA Label for Topical Pain Relief
View Indications, Usage & Precautions
Topical Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Leon Medical Centers, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine HCl, USP 4%
Otc - Purpose
Topical Anesthetic
Indications & Usage
Use
Temporarily relieves minor pains
Warnings
Warnings
For external use only
Do not use
- on large areas of the body or on cut, irritated, or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
- use only as directed. Read and follow all directions and warnings on this label
- do not allow contact with eyes
- do not handage or apply local heat (such as heating pads) to the area of use.
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
When using this product
Stop use and ask a doctor if
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children over 12 years of age
- Apply generously to the affected area as needed every 6-8 hours, not to exceeed 3 application in a 24 hour period.
- Not for use in children under 12 years of age
Inactive Ingredient
Inactive ingredients
camphor, glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water and xantham gum.
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