NDC 68577-008 Earth To Skin Watermelon Hand Sanitizer 2.0 Oz

Alcohol

NDC Product Code 68577-008

NDC 68577-008-00

Package Description: 60 mL in 1 BOTTLE

NDC Product Information

Earth To Skin Watermelon Hand Sanitizer 2.0 Oz with NDC 68577-008 is a a human over the counter drug product labeled by Nu-world Corporation. The generic name of Earth To Skin Watermelon Hand Sanitizer 2.0 Oz is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Nu-world Corporation

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Earth To Skin Watermelon Hand Sanitizer 2.0 Oz 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 72 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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ETHOHEXADIOL (UNII: M9JGK7U88V)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • WATERMELON (UNII: 231473QB6R)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Nu-world Corporation
Labeler Code: 68577
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.

Earth To Skin Watermelon Hand Sanitizer 2.0 Oz Product Label Images

Earth To Skin Watermelon Hand Sanitizer 2.0 Oz 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 the
  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
  • 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) consistent with World Health Organization (WHO) recommendations:Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).Hydrogen peroxide (0.125% v/v).Sterile distilled water or boiled cold water.The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(S)

Alcohol 72% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

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

Inactive Ingredients-Earth To Skin Scent Free Hand Sanitizer 2.0 Oz

Water, Butylene Glycol,Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate,Carbomer, Aminomethyl Propanol, Ethyl Hexanediol, Phenoxyethanol

Inactive Ingredients-Earth To Skin Blueberry Hand Sanitizer 2.0 Oz

Water,Vaccinium Angustifolium (Blueberry) Fruit Extract, Aloe Barbadensis Leaf Juice,Butylene Glycol, Glycerin, Propanediol, Isopropyl Myristate,Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Benzyl Benzoate,Benzyl Alcohol,Linalool,Benzyl Cinnamate, Ethyl Hexanediol, Phenoxyethanol

Inactive Ingredient-Earth To Skin Watermelon Hand Sanitizer 2.0 Oz

Water, Citrullus Lanatus (Watermelon) Fruit Extract, Aloe Barbadensis Leaf Juice, Glycerin, Butylene Glycol, Isopropyl Myristate,

Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Limonene, Benzyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Ethyl Hexanediol, Phenoxyethanol

Inactive Ingredient-Earth To Skin Lemon + Basil Hand Sanitizer 2.0 Oz

Water, Lactobacillus/Lemon Peel Ferment Extract, Ocimum Basilicum (Basil) Oil, Aloearbadensis Leaf Juice, Butylene Glycol, Glycerin, Ethylhexyl Palmitate, Isopropyl Myristate, Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Citral, Hexyl Cinnamal, Limonene, Ethyl Hexanediol, Phenoxyethanol

Inactive Ingredient-Earth To Skin Coconut + Aloe Hand Sanitizer 2.0 Oz

Water, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Water, Cocos Nucifera (Coconut) Fruit Juice,Glycerin, Butylene Glycol, Isopropyl Myristate, Carbomer, Aminomethyl Propanol, Fragrance(Parfum), Limonene, Eugenol, Ethyl Hexanediol, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

Packag Labl. Principal Dispaly Panel-Earth To Skin Watermelon Hand Sanitizer 2.0 Oz Front

60ML NDC:68577-008-00

Package Label. Principal Display-Earth To Skin Watermelon Hand Sanitizer 2.0 Oz Back

60ML NDC:68577-008-00

* Please review the disclaimer below.