NDC 77210-0002 Hand Sanitizer

Alcohol

NDC Product Code 77210-0002

NDC 77210-0002-1

Package Description: 1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC 77210-0002-2

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 77210-0002-3

Package Description: 30 mL in 1 BOTTLE, PLASTIC

NDC 77210-0002-4

Package Description: 60 mL in 1 BOTTLE, PLASTIC

NDC 77210-0002-5

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 77210-0002-6

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 77210-0002-7

Package Description: 3800 mL in 1 JUG

NDC 77210-0002-8

Package Description: 20000 mL in 1 JUG

NDC 77210-0002-9

Package Description: 200000 mL in 1 DRUM

NDC Product Information

Hand Sanitizer with NDC 77210-0002 is a a human over the counter drug product labeled by Exportadora In & Out S De Rl De Cv. The generic name of Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Exportadora In & Out S De Rl De Cv

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.

Hand Sanitizer 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

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: Exportadora In & Out S De Rl De Cv
Labeler Code: 77210
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: 05-07-2020 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’.

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Hand Sanitizer Product Label Images

Hand Sanitizer 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

Ethyl Alcohol v/v 70%

Purposes

Antimicrobial

Uses

-Hand sanitizer to decrease virus and bacteria on the skin that could cause diseases-Recommended for repeated use

Warnings

For external use only: handsFlammable, keep away from fire or flame

When Use This Product

Keep out of eyes, do not use in or near the eyes.In case of contact eye flush thorougly with wateravoid contact with broken skindo not inhale or ingest

When Using This Product

Keep out of eyes, do not use in or near the eyes

Stop Use And Ask A Doctor If

Irritation and redness developcondition persist for more than 72 hours. Keep out reach of children. If swallowed, get medical help or contact Poison Control Center right away

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Center right away

Directions

-Put enough product in your palm to cover hands and rub hands together briskly until dry out without wiping-For children under 6 years of age should be supervised when using OZO-Not recommended for infants

Other Information

Store below 105 F (40C)May discolor certain fabricsHarmful to wood finishes and plastics

Inactive Ingredients

Purified water (aqua), Vegetable Glycerin and carboxymethyl cellulose

For The 20 Lt, 200Lt And 1000Lt Label

Keep in original container an away form heat, open flames, combustible materials and hot surfaces, no smoking,- Harmful is Swallowed"First aid: first check the victim for contact eyes lenses and removes if presents. Flush victim's eye with water or normal saline solution for 20 to 30 minutes while simultaneoulsy calling a hospital or poison control center, Do not put any oinments, oils, medication in the victim's eye without specific instructions from a physician.IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop.INGESTION: DO NOT INDUCE VOMIT. Volatile chemicals have a high risk of being aspirated into the victims lungs during vomiting wich increase the medical problems. If the victim is conscious and not convulsing, give 1 or 2 glasses of water to dilute the chemical and IMMEDIATLY transport the victim to a hospital. If the victim is convulsing or unconscious, do not give anything by mouth, ensure that the victims airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATLY transport the victim to a hospital:Firefighting CAUTION: all these products have a very low flash point: use water spray when fighting fire may be inefficient: CAUTION: Alcohol-resistant foam should be used.SMALL FIRE: Dry Chemicals, co2, water spray or alcohol-resistant foam. LARGE FIRE: Water spray, fog or alcohol resistant foam. Do not use straight streams. Move containers from fire area if you can do it without risk. FIRE INVOLVING TANKS OR CAR/TRAILERS LOADS: Fight fire for maximun distance or use unmanned hose holders or monito nozzles: Cool containers with flooding quiantities of water until well after fire is out. Withdraw immediatly in case of rising sounf from venting safety devices or discoloration of thank. ALWAYS stay away from tanks engulfed in fire. For massive fire, use unmaned hose holders or monitor nozzles; if this is imposible. Withdraw from area and let the fire burn.

Principal Display

OZONE, hand sanitizer gel
antiviral & bacterial ozonized gelleaves hands softcontains moisturizersparaben freephthalate freeformaldehyde Donor Free

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