Otc - Active Ingredient
Active ingredient Purosose
Menthol 10%......................Topical analgesic
Deep Blue Mini Stick
FDA Label NDC 71630-035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Doterra International, Llc for the product Deep Blue Mini (NDC 71630-035). 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, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses for the temporary relief of minor aches and pains of
muscles and joints associated with: • simple backache •
arthritis • sprains • strains • bruises
Warnings
Warnings: For external use only
Otc - When Using
When using this product • use only as directed • avoid getting into the eyes
or on mucous membranes. If contact occurs, rinse thoroughly with water.
• do not apply to wounds or damaged skin
• do not bandage tightly or use with a heating pad
Otc - Stop Use
Stop use and ask a doctor if • irritation or redness occur •
nausea, vomiting, abdominal discomfort, diarrhea, or skin rash
occurs • pain persists for more than 7 days, or redness is present,
or in conditions affecting children under 12 years of age
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health care professional
before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If accidentally ingested,
get medical help or contact a
Poison Control Center immediately.
Instructions For Use
Directions:
adults and children over 12 years: apply generously to
affected area. Repeat as necessary, but not more than 4 times daily.
children under 12 years of age: consult a doctor
Storage And Handling
Other information • Store at a temperature below 38°C/100°F •
Do not use if seal is broken • Close cap tightly after use
Inactive Ingredient
Inactive ingredients Cocos nucifera (Coconut) Oil, Tapioca Starch,
Gaultheria procumbens (Wintergreen) Leaf Oil, Helianthus annuus
(Sunflower) Seed Wax, Copaifera coriacea/langsdorffii/officinalis/
reticulata Resin Oil, Water (Aqua), Sambucus nigra Fruit Extract,
Prunus amygdalus dulcis (Sweet Almond) Oil, Glyceryl Laurate,
Glyceryl Caprylate, Mentha piperita (Peppermint) Oil, Cinnamomum
camphora (Camphor) Oil, Eucalyptus globulus Leaf Oil, Tanacetum
annuum Flower/Leaf/ Stem Oil, Glyceryl Undecylenate, Cananga
odorata Flower Oil, Capsicum frutescens Fruit Extract, Glycerin,
Lauric Acid, Chamomilla recutita (Matricaria) Oil, Helichrysum
italicum Flower/Leaf/Stem Oil, Citric Acid
Otc - Questions
Questions or comments?
Call 1-800-411-8151
Indications & Usage
Uses for the temporary relief of minor aches and pains of
muscles and joints associated with: simple backache
arthritis, sprains, strains, bruises
Dosage & Administration
Directions: adults and children over
12 years: apply generously to affected
area. Repeat as necessary, but not
more than 4 times daily.
children under 12 years of age:
consult a doctor.
* Please review the disclaimer below.
