NDC 76305-302 Aulief Topical Pain Reliever

Menthol And Camohor

NDC Product Code 76305-302

NDC Code: 76305-302

Proprietary Name: Aulief Topical Pain Reliever What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol And Camohor What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 76305 - China-gel, Inc.
    • 76305-302 - Aulief

NDC 76305-302-01

Package Description: 90.7 g in 1 TUBE

NDC 76305-302-02

Package Description: 198.5 g in 1 TUBE

NDC 76305-302-03

Package Description: 453.6 g in 1 BOTTLE

NDC Product Information

Aulief Topical Pain Reliever with NDC 76305-302 is a a human over the counter drug product labeled by China-gel, Inc.. The generic name of Aulief Topical Pain Reliever is menthol and camohor. The product's dosage form is cream and is administered via topical form.

Labeler Name: China-gel, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Aulief Topical Pain Reliever 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.

  • CAMPHOR (NATURAL) 30 mg/g
  • MENTHOL 50 mg/g

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.

  • LAVANDIN OIL (UNII: 9RES347CKG)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ALCOHOL (UNII: 3K9958V90M)
  • PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
  • WATER (UNII: 059QF0KO0R)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • ANGELICA POLYMORPHA ROOT (UNII: HZ12173363)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER 980 (UNII: 4Q93RCW27E)
  • WITCH HAZEL (UNII: 101I4J0U34)

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: China-gel, Inc.
Labeler Code: 76305
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: 05-14-2019 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: 12-31-2020 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.

Aulief Topical Pain Reliever Product Label Images

Aulief Topical Pain Reliever 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 Ingredients

Organic Camphor 3.00%Organic Menthol 5.00%

Purpose

Topical AnalgesicTopical Analgesic

Uses

  • For temporary relief of minor aches and pains of muscles and joints associated with:arthritisbursitissimple backachesports injuries

Warnings

  • For external use onlyAvoid contact with eyes and mucous membranes

Do Not Use

  • With bandages or heating padwith heat or open flameon open wounds or open skinwith other topical productsif skin irritation occurs

Otc - Ask Doctor

Stop use and ask a doctor if pain persists more than 7 days, or returns within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Adults or children 2 years of age or olderCleanse the area-apply liberally over affected area as neededMassage into skin until absorbedRepeat up to 4 times a day

Other Information

  • Store in cool, dry placeMinor separation may occurKeep closed when not in use

Inactive Ingredients

Alcohol*, Aloe Barbadensis, Leaf Extract*, Angelica Polymorpha Sinensis Root Extract*, Carbomer, Hamamelis Virginiana (Witch Hazel)*, Lavandin Grosso (lavender)*, Panex Ginseng Root Extract*, Polysorbate 60, Potassium Hydroxide, Water(
*certified organic ingredient)

Questions?

1-800-898-4435

Principal Display

Aulief®
topical pain reliefContains Organic HerbsNet Wt. 16oz. (453.6g)

* Please review the disclaimer below.

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