Elp Essential Manteca De Ubre Ointment
FDA Label NDC 79974-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miramar Cosmetics, Inc Dba Miramar Lab for the product Elp Essential Manteca De Ubre (NDC 79974-210). 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 drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Methyl Salicylate 10%
Camphor 4%
Purpose
Topical Analgesic
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.
Warnings
For external use only • Avoid contact with eyes • Avoid mucous membranes
Do Not Use
In open wounds or damaged skin, with a heating pad, or with a tight bandage.
Stop use and Ask the doctor if.
You are allergic to Salicylate or any of this product's inactive ingredients, symptoms persist for more than seven days, redness is present or excessive irritation on the skin develops.
If pregnant or breast feeding. Contact a physician 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.
Directions
Wash the area with mild soap and warm water, rinse thoroughly. Apply generously and gently massage the affected area not more than 1 to 4 times daily. For Adults and Children 12 years of age and older. Children under 12 years of age or younger, ask a doctor.
Other Information
Tamper Evident Feature Do not use if seal under cap is torn, broken or missing. Store at 15° to 25° C (59° to 77° F)
Inactive Ingredients
Snow White Petrolatum, Tea Tree Oil, Eucalyptus Oil, Menthol, D&C Yellow.
Questions Or Comments?
Call 786 6469178 Weekdays from 9:30 Am to 4:30 Pm Eastern time.
Packaging
Udderbalm1 (79974210 1)
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