Extra Strength Eez-away
FDA Label NDC 69678-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eezaway Relief Inc for the product Extra Strength Eez-away (NDC 69678-121). 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 drug facts, active ingredient:, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Menthol 2.50%
Purpose
Topical Analgesic
Uses
temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises ■ cramps
Warnings
For external use only
When using this product ■ use only as directed ■ do not bandage tightly or use with heating pad ■ avoid contact with eyes and mucous
membranes ■ do not apply to wounds or damaged, broken or irritated skin ■ a transient burning sensation or redness may occur upon
application but generally disappears in several days ■ if severe burning sensation occurs, discontinue use immediately ■ do not
expose the area treated with product to heat or direct sunlight
Stop use and ask a doctor if ■ Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
Flammable ■ keep away from fire or flame
If pregnant or breast-feeding, ask a health professional 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.
Directions
adults and children over 12 years: ■ apply generously to affected area ■ massage into painful area until thoroughly absorbed into skin
■ repeat as necessary, but no more than 3 to 4 times daily
■ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
children 12 years or younger: ask a doctor
Inactive Ingredients
Emu Oil, Fragrance, Full Spectrum Hemp Extract, Glucam P-20, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate Crystal USP, Tincture of Iodine USP
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