Otc - Active Ingredient
Active Ingredients
Lidocaine HCL 4 %
Tough Love Pain Relieving Cream
FDA Label NDC 62742-4222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Tough Love Pain Relieving (NDC 62742-4222). 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 - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain Reliver
Indications & Usage
Uses
Temporarily relieves minor pain associated with Muscle strains,sprain and simple backache,insect bites.
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not uses
Do not apply to wounds or damaged skin
Otc - When Using
When using this Product use only as directed
do not bandage tightly or use with a heating pad
Otc - Stop Use
Stop uses
Condition Worsens
Symptoms persist for more than 7 days or clear up and occur again within a few days
Redness is present
Irritation develops
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
Direction
Adults and children over 12 years of age
apply externally to affected area up to 2-3 time a day.
repeat as necessary, but no more than 4 time daily.
children 12 year or younger ask a doctor
Other Safety Information
Other safety information and warning
Warning: For adults only. Consult your physician before use if you are pregnant, lactating, taking medications, or have a medical condition. Keep out of reach of children.
Warning: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to www.p65warnings.ca.gov.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
Inactive Ingredient
Inactive Ingredient
Water ((Aqua), Glyceryl stearate, Butyrospermum Parkii Nut Extract, glycerin, Ceteraryl Alcohol, Broad Spectrum Hemp Extract, Cetearyl Olivate, Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Sorbitan Olivate, stearic Acid, Candelilla/Jojoba/Rice Bran Polyglyceride-3Esters, Linum Usitatissimum(Linseed) Seed Oil, Sodium Phytate,Xanthan Gum, Hydroxyapatite, Citric Acid,Tocopherol,
Persea Gratissima (Avocado) Oil,Sodium Stearoyl Lactylate,Viburnum Opulus Bark Extract, Alcohol,Glycyrrhiza Glabra (Licorice) Root Extract, Lavandula Angustifolia (Lavender)Oil,Cananga Odorata Flower Oil, Melia Azadirachta Flower Extract,Corallina Officinalis Extract,Cocconia Indica Fruit Extract,Melia Azadirachta Leaf extract,Solanum Melongena (Eggplant) Fruit Extract, Aloe Barbadensis Flower Extract,Ocimum Sanctum Leaf Extract,Curcuma Longa (Turmeric) Root Extract, Phenoxyethanol,Caprylyl Glycol,Ethylhexylglycerin, Hexylene Glycol
Package Label.Principal Display Panel
Toughlovepainrelieving (Toughlovepainrelieving)
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