NDC 80533-001 Instant Hand Sanitizer
Instant Hand Sanitizer
NDC Product Code 80533-001
Proprietary Name: Instant Hand Sanitizer 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: Instant Hand Sanitizer 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
- 80533 - Nanxiong Singlong Chemicals Co.,ltd.
- 80533-001 - Instant Hand Sanitizer
NDC 80533-001-01
Package Description: 8 mL in 1 BOTTLE
NDC 80533-001-02
Package Description: 30 mL in 1 BOTTLE
NDC 80533-001-03
Package Description: 50 mL in 1 BOTTLE
NDC 80533-001-04
Package Description: 60 mL in 1 BOTTLE
NDC 80533-001-05
Package Description: 100 mL in 1 BOTTLE
NDC 80533-001-06
Package Description: 250 mL in 1 BOTTLE
NDC 80533-001-07
Package Description: 300 mL in 1 BOTTLE
NDC 80533-001-08
Package Description: 500 mL in 1 BOTTLE
NDC 80533-001-09
Package Description: 1000 mL in 1 BOTTLE
NDC Product Information
Instant Hand Sanitizer with NDC 80533-001 is a a human over the counter drug product labeled by Nanxiong Singlong Chemicals Co.,ltd.. The generic name of Instant Hand Sanitizer is instant hand sanitizer. The product's dosage form is gel and is administered via topical form.
Labeler Name: Nanxiong Singlong Chemicals Co.,ltd.
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.
Instant 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.
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.
- GLYCERIN (UNII: PDC6A3C0OX)
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- WATER (UNII: 059QF0KO0R)
- TROLAMINE (UNII: 9O3K93S3TK)
- CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
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: Nanxiong Singlong Chemicals Co.,ltd.
Labeler Code: 80533
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: 03-30-2020 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.
Instant Hand Sanitizer Product Label Images
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80533-001-01 8ml - 80533 001 01 8ml
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80533-001-02 30ml - 80533 001 02 30ml
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80533-001-03 50ml - 80533 001 03 50ml
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80533-001-04 60ml - 80533 001 04 60ml
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80533-001-05 100ml - 80533 001 05 100ml
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80533-001-06 250ml - 80533 001 06 250ml
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80533-001-07 300ml - 80533 001 07 300ml
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80533-001-08 500ml - 80533 001 08 500ml
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80533-001-09 1000ml - 80533 001 09 1000ml
Instant 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(S)
- Purpose
- Use
- Warnings
- Do Not Use
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Other Information
- Inactive Ingredients
Active Ingredient(S)
Ethyl Alcohol 75%v/v
Purpose
Antimicrobial
Use
Hand sanitizer to help reduce bacteria on skin
Warnings
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes, In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash appears and lastsKeep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Do Not Use
Do not use in or near the eyes, In case of contact, rinse eyes thoroughly with water.
Otc - When Using
When using this product do not use in or near the eyes, In case of contact, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash appears and lastsKeep 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 appears and lasts
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
Put enough product in your palm to cover hands and rub hands together briskly until dry
Children under 6 years of age should be supervised
Other Information
Store below 86°F/30°C
May discolor certain fabrics or surfaces
Inactive Ingredients
Water, Glycerin, Aloe Barbadensis Leaf Extract, Acry1ates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine
* Please review the disclaimer below.