Otc - Active Ingredient
Menthol 1.5%
Achy
FDA Label NDC 71157-0017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kelada Creative Group Llc Dba Salve for the product Achy (NDC 71157-0017). 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, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.
Warnings
Warnings
For external use only.
Do not use other than directed
When using this product
- avoid contact with eyes and mucous membranes
- do not apply tp wounds or broken skin
- excessive skin irritation develops
- condition worsens
Stop use and ask a doctor if
Dosage & Administration
Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily
Children under 3 years of age ask a doctor before using
Inactive Ingredient
Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222
Indications & Usage
Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.
Package Label.Principal Display Panel
Achy (Achy)
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