NDC 71630-882 Deep Blue Copaiba

Menthol

NDC Product Code 71630-882

NDC 71630-882-48

Package Description: 48 g in 1 CYLINDER

NDC Product Information

Deep Blue Copaiba with NDC 71630-882 is a a human over the counter drug product labeled by Doterra International, Llc. The generic name of Deep Blue Copaiba is menthol. The product's dosage form is stick and is administered via topical form.

Labeler Name: Doterra International, Llc

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Deep Blue Copaiba Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 10 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • CAMPHOR OIL (UNII: 75IZZ8Y727)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CANANGA OIL (UNII: 8YOY78GNNX)
  • SAMBUCUS NIGRA SUBSP. CERULEA FRUIT (UNII: EPM36Z6E4L)
  • GLYCERYL LAURATE (UNII: Y98611C087)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • TANACETUM ANNUUM FLOWERING TOP OIL (UNII: E2Q02N1ZC7)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • TABASCO PEPPER (UNII: J1M3NA843L)
  • LAURIC ACID (UNII: 1160N9NU9U)
  • WATER (UNII: 059QF0KO0R)
  • COPAIBA OIL (UNII: 64VX45Y68N)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Doterra International, Llc
Labeler Code: 71630
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-17-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Deep Blue Copaiba Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient Menthol 10%

Otc - Purpose

Topical analgesic

Indications & Usage

Uses for the temporary relief of minor aches

and pains of muscles and joints associated with:

• simple backache • arthritis • sprains

• strains • bruises

Warnings

For external use only

Allergy alert: Do not use if allergic to

salicylates (including aspirin) without

consulting a physician.

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 - 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.

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

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

Other Safety Information

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

Dosage & Administration

Active Ingredient Purpose

Menthol 10%................... Topical analgesic

* Please review the disclaimer below.