Otc - Active Ingredient
Lidocaine HCl 4%, Menthol 1%
Heal And Rescue Bunion Pain Relief Gel
FDA Label NDC 29784-410
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rooftop Consumer Health, Inc for the product Heal And Rescue Bunion Pain Relief (NDC 29784-410). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves minor pain.
Warnings
For external use only.Flammable. Keep away from fire or flame. Do not use if you have an allergic reaction to Lidocaine HCl or other local anesthetics, on large areas of the body or on cut, irritated, blistered, or swollen skin, puncture wounds, for more than one week without consulting a doctor.
When using this product use only as directed. Read and follow all directions and warnings on this carton, avoid contact with eyes and mucous membranes, rare cases of serious burns have been reported with products of this type, do not apply to wounds or damaged, broken, or irritated skin, do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use, a transient burning sensation may occur upon application but generally disappears in several days, avoid applying into skin folds.
Stop use and ask a doctor if condition worsens, severe burning sensation, redness, rash or irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Dosage & Administration
Adults and children 12 years and older: apply to the affected area, not more than 6 to 8 hours. Do not exceed 3 applications in a 24-hour period. Massage into painful area until thoroughly absorbed into the skin. AFTER APPLYING WASH HANDS WITH SOAP ANDWATER. Children under 12 years of age: ask a doctor.
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Aloe Barbadensis Leaf Extract, 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, Methylparaben, Polysorbate 60, Steareth-21, Water.
* Please review the disclaimer below.
