Otc - Active Ingredient
Active Ingredients
Menthol 51 mg / patch
Methyl Salicylate 15 mg / patch
Imbue
FDA Label NDC 75979-1146
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Imbue Body Llc for the product Imbue (NDC 75979-1146). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, 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
Topical Analgesic
Topical Analgesic
Indications & Usage
Uses: Temporarily relieves minor aches and pains of muscles and joints associated with:
• simple backache • muscle strain • sprains • arthritis • bruises • bursitis • tendinitis.
Warnings
Warnings FOR EXTERNAL USE ONLY
Otc - When Using
When using this product:
• Use only as directed
• Do not get into eyes or on mucus membranes
• Do not apply to wounds, damaged or irritated skin
• Do not bandage tightly or use with a heating pad
Otc - Stop Use
Stop use and ask a doctor if:
• Condition worsens
• Severe skin irritation develops
• Pain persists for more than 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health care 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.
Dosage & Administration
Directions
Adults and children over 12 years:
• Peel clear film off carefully. Avoid letting the sticky surface of the patch adhere to itself.
• Place sticky surface of patch on skin, covering as much of the painful area as possible.
• Leave in place for up to 8 hours. Pain relief is occasionally delayed.
• Use 1 - 2 patches per day. Wait 12 - 24 hours before applying additional patches, to avoid skin irritation.
• Wash hands after applying patch.
• If patch is difficult to remove from skin, soak in warm water or vegetable oil, then peel off slowly.
• Patch may be cut to size (before removing protective film) to treat smaller areas.
• See Additional Tips for more helpful information.
Children 12 years or younger: ask a doctor before use.
Other
Other Information
• This product may cause skin rash in some individuals.
• Store in a cool area away from direct sunlight.
• Always re-seal pouch containing unused patches.
Inactive Ingredient
Inactive Ingredients: Acorus gramineus rhizome, Angelica sinensis root, Artemisia argyi leaf, Atractylodes lancea rhizome, black sesame oil, Boswellia carterii resin, Carthamus tinctorius flower, Cinnamomum verum bark, Cnidium monnieri fruit, Commiphora myrrha resin, Cyathula officinalis root, Cymbopogon citratus essential oil, Dioscorea hypoglauca rhizome, Drynaria fortunei rhizome, Eletherococcus nodiflorus root cortex, Ephemerantha fimbriata aerial parts, Gentiana macrophylla root, Helichrysum italicum essential oil, Lavandula angustifolia essential oil, Ligusticum chuanxiong root, Paeonia lactiflora root, Pinellia ternata rhizome, Pinus massoniana resin, Saussurea lappa root, zinc oxide.
* Please review the disclaimer below.
