Active Ingredient(S)
Lidocaine HCl 4%
Menthol 1%
The following Structured Product Label (SPL) was submitted to the FDA by Garcoa, Inc. for the product Blue Goo Nerve Ease Pain Relief (NDC 67385-825). 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 ingredient(s), purpose, use(s), warnings, directions, inactive ingredients, questions, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine HCl 4%
Menthol 1%
Topical analgesic
Topical analgesic
Use for the temporary relief of pain.
WARNINGS
For External use only.
Do not use • in large quantities, particularly over raw surfaces or blistered areas • if you are allergic to lidocaine or other local anesthetics • on damages, broken skin • on cuts, swollen or irritated skin • for more than a week without consulting a physician.
When using this product • use only as directed • avoid contact with the eyes • do not use with heating pads, medicated patches or heating devices • do not bandage tightly • read and follow all directions and warnings on this carton • avoid applying into skin folds •do not apply over large areas of the body • a slight burning sensation may occur upon application but usually disappears in several days.
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 • pain, swelling, blistering develops where product is used • redness, rash, itching, irritation develops where product is used.
Flammable • keep away from fire or flame.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children and pets. if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions Adults and children 12 years age and older • clean and dry affected area •apply a thin layer to affected area not more than 3 times daily • do not apply more than three times within 24 hours • massage into painful area until thoroughly absorbed into the skin • wash hands after use with soap and water. Children under 12 years of age: do not use, consult a doctor.
Inactive ingredients acrylates/Cl10-30 alkyl acrylate crosspolymer, alcohol denat.,
aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone,
cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA,
ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate
copolymer, isohexadecane, phenoxyethanol, polysorbate 60, steareth-21, water.
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