Active Ingredients
Calendula Officinalis Flower Extract (4%)
My Medic Calendula Gel
FDA Label NDC 81417-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sled Distribution, Llc for the product My Medic Calendula (NDC 81417-007). 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 ingredients, purpose section, uses, warnings, otc - do not use, otc - when using, otc - stop use, 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
Purpose Section
Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.
Uses
temporarily relieve muscle pain and stiffness due to:
- minor infuries
- overexertion
- falls
- reduces symptoms of bruising such as
- discoloration
- pain
- swelling
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic to Calendula or any of this product's inactive ingredients.
Otc - When Using
When using this product
- avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
- dryness or irritation may occur
- use only as directed
- do not tightly wrap or bandage the treated area
- do not apply heat or ice to the treated area immediately before or after use.
Otc - Stop Use
Stop use and ask a doctor if
- conditions persist for more than3 days or worsens
- symptoms clear up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.
Other Information
do not use if the sachet seal is broken.
Inactive Ingredients
White Petroleum, Water
Package Label.Principal Display Panel
Image Of Pouch Label (5)
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