NDC 76751-611 Olika Hand Sanitizer Lavender

Ethyl Alcohol

NDC Product Code 76751-611

NDC 76751-611-01

Package Description: 30 mL in 1 BOTTLE, PUMP

NDC 76751-611-02

Package Description: 20 mL in 1 BOTTLE, PUMP

NDC 76751-611-03

Package Description: 90 mL in 1 POUCH

NDC Product Information

Olika Hand Sanitizer Lavender with NDC 76751-611 is a a human over the counter drug product labeled by Perkin And Perkin Llc. The generic name of Olika Hand Sanitizer Lavender is ethyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Perkin And Perkin Llc

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 Hand Sanitizer Lavender 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 65 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.

  • 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
  • .DELTA.-DECALACTONE (UNII: CNA0S5T234)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • VANILLIN (UNII: CHI530446X)
  • CARDAMOM OIL (UNII: JM0KJ091HZ)
  • METHYL ANTHRANILATE (UNII: 981I0C1E5W)
  • CITRUS SINENSIS LEAF (UNII: VF01D90MZI)
  • CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
  • .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
  • .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)
  • MANDARIN OIL (UNII: NJO720F72R)
  • CLOVE LEAF OIL (UNII: VCA5491KVF)
  • CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
  • ALLYL HEXANOATE (UNII: 3VH84A363D)
  • LEMON OIL (UNII: I9GRO824LL)
  • PIPERONAL (UNII: KE109YAK00)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • LINALOOL, (-)- (UNII: 3U21E3V8I2)
  • .ALPHA.-TERPINEOL (UNII: 21334LVV8W)
  • PALMAROSA OIL (UNII: 0J3G3O53ST)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • MALTOL (UNII: 3A9RD92BS4)
  • .DELTA.-DODECALACTONE (UNII: 33DIC582TL)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • LITSEA OIL (UNII: 2XIW34BN6O)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
  • VANILLIN (UNII: CHI530446X)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • LAVANDIN OIL (UNII: 9RES347CKG)
  • LEMON OIL (UNII: I9GRO824LL)
  • LINALOOL, (-)- (UNII: 3U21E3V8I2)
  • AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
  • POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
  • BULNESIA SARMIENTOI WOOD OIL (UNII: 81H0L6W02F)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)

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: Perkin And Perkin Llc
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: 06-01-2020 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.

Olika Hand Sanitizer Lavender 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

  • These products are hand sanitizers manufactured according to the 1994 tentative final monograph for antiseptics with additional guidance taken from subsequent rule makings and guidances.The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation).Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.Glycerol (4.2% v/v).Aloe Barbadensis Leaf Extract.Sterile distilled water or boiled cold water.Fragrance The finished product formulation underwent third party efficacy testing (kill study) to confirm efficacy and product potency. The hand sanitizer come in 6 different scents. Fragrance free (submitted separately NDC 76751-211), Lavender (NDC 76751-611), Orange Blossom (NDC 76751-511), Mint Citrus (NDC 76751-111), Charcoal (NDC 76751-311) and Cucumber Basil (NDC 76751-411).

Active Ingredient(S)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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.

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

Otc - Stop Use

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.

Other Information

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

Use

Helps reduce bacteria on skin.

Directions

  • Remove nozzel bead.Spray liquid in hands and rub until dry.Use as often as needed.

Inactive Ingredients

  • Inactive Ingredients for NDCs 76751-111-01; 76751-311-01; 76751-411-01; 76751-511-01; 76751-611-01Aloe Barbadensis Leaf ExtractFragrance (Essential Oil Blend)GlycerinWater

76751-411-01 Prinicipal Display Panel And Information Panel Image

30 mL NDC 76751-411-01

76751-111-01 Prinicipal Display Panel And Information Panel

30 mL NDC 76751-111-01

76751-111-02 Principal Display And Information Panel

20 mL NDC 76751-111-02

76751-311-02 Principal Display And Information Panel

20mL NDC 76751-311-02

76751-111-03 Principal Discplay Panel And Information Panel

90 mL NDC 76751-111-03

* Please review the disclaimer below.