NDC 71630-383 On Guard Sanitizing Wipes

Alcohol

NDC Product Code 71630-383

NDC 71630-383-11

Package Description: 70 mL in 1 PACKET

NDC 71630-383-20

Package Description: 1400 mL in 1 CARTON

NDC Product Information

On Guard Sanitizing Wipes with NDC 71630-383 is a a human over the counter drug product labeled by Doterra International, Llc. The generic name of On Guard Sanitizing Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Doterra International, Llc

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

On Guard Sanitizing Wipes 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.

  • ALCOHOL 70 mL/100mL

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.

  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CINNAMON LEAF OIL (UNII: S92U8SQ71V)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • CLOVE OIL (UNII: 578389D6D0)
  • CINNAMON BARK OIL (UNII: XE54U569EC)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ORANGE OIL (UNII: AKN3KSD11B)

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.
  • 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: part333A 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: 10-30-2020 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: 12-31-2021 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 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.

On Guard Sanitizing Wipes 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

Active Ingredient(S)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

•Decreases bacteria on hands [skin].

•Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

Otc - When Using

Do not use in or near the eyes. In case of contact, rinse eyes thoroughly with waterStop use and ask a doctor if irritation or rash appears and lasts.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs and lasts.

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

Wet hands thoroughly with wipe and allow to dry without rinsing. Throw away after use. Do not flush.

Other Information

  • Store at a temperature below 38 C (100 F).

Inactive Ingredients

Water (Aqua), Glycerin, Citrus aurantium dulcis (Orange) Peel Oil, Eugenia caryophyllus (Clove) Bud Oil, Cinnamomum zeylanicum Leaf Oil, Cinnamomum zeylanicum Bark Oil, t-butyl

Alcohol, Eucalyptus globulus Leaf Oil, Rosmarinus officinalis (Rosemary) Leaf/Stem Oil, Camellia sinensis Leaf

Extract, Denatonium Benzoate, Aloe barbadensis Leaf Extract, Althaea officinalis Root Extract, Chamomilla recutita (Matricaria) Flower Extract, Cucumis sativus (Cucumber) Fruit Extract, Avena sativa (Oat) Kernel Extract.

* Please review the disclaimer below.