NDC 76751-713 Olika Hydrating Hand Sanitizer Frosted Eucalyptus

Alcohol

NDC Product Code 76751-713

NDC 76751-713-01

Package Description: 90 mL in 1 POUCH

NDC 76751-713-02

Package Description: 1 BOTTLE, SPRAY in 1 BLISTER PACK > 20 mL in 1 BOTTLE, SPRAY (76751-713-00)

NDC Product Information

Olika Hydrating Hand Sanitizer Frosted Eucalyptus with NDC 76751-713 is a a human over the counter drug product labeled by Olika Inc.. The generic name of Olika Hydrating Hand Sanitizer Frosted Eucalyptus is alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 902515.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Olika Hydrating Hand Sanitizer Frosted Eucalyptus 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.


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.

  • ACETYL CEDRENE (UNII: X6I62755AK)
  • IONONE (UNII: QP734LIN1K)
  • ETHYL LINALOOL (UNII: SF2JS9GF5T)
  • ETHYL BUTYRATE (UNII: UFD2LZ005D)
  • FLORALOZONE (UNII: 1HA71K8K9L)
  • METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
  • ALLYL HEPTANOATE (UNII: AU4CYG9V68)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • DIHYDROMYRCENOL (UNII: 46L1B02ND9)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • 3-ISOCAMPHYLCYCLOHEXANOL, TRANS- (UNII: 34UP96K73Z)
  • NERYL ACETATE (UNII: OF82IJU18H)
  • HEXYL ACETATE (UNII: 7U7KU3MWT0)
  • GERANYL ACETATE (UNII: 3W81YG7P9R)
  • ETHYL ACETOACETATE ETHYLENEGLYCOL KETAL (UNII: G5EXI4NID0)
  • PENTADECALACTONE (UNII: OK17S3S98K)
  • CYCLOPENTANONE (UNII: 220W81TN3S)
  • ETHYL 2,4-DECADIENOATE, (2E,4Z)- (UNII: 79P6KS9Y5Z)
  • 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
  • ALLYL .ALPHA.-IONONE (UNII: 8IP66F9ODG)
  • ALLYL HEXANOATE (UNII: 3VH84A363D)
  • ALLYL CYCLOHEXANEACETATE (UNII: M6J8835739)
  • 3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • REISHI (UNII: TKD8LH0X2Z)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

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: Olika Inc.
Labeler Code: 76751
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: 06-14-2021 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Olika Hydrating Hand Sanitizer Frosted Eucalyptus 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

Other

This is a hand sanitizer manufactured according to the1994 tentative final monograph for hand sanitizers and antiseptics. Final formulation finished product testing was performed to confirm efficacy and quality assurance.The formulation comes in 2 package sizes: 20 mL and 90mL

Active Ingredient(S)

Ethyl Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Helps reduce bacteria on skin.

Warnings

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

Do Not Use

  • In children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Spray liquid into hands and rub until dry. Use as often as needed.

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Aloe vera, fragrance, glycerin, hyaluronic acid, reishi mushrooms, water

* Please review the disclaimer below.