NDC 78692-613 Alobon Sanitizerspray

Sanitizer Spray

NDC Product Code 78692-613

NDC 78692-613-34

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Alobon Sanitizerspray with NDC 78692-613 is a a human over the counter drug product labeled by Shantou Wanbang Cosmetic Co., Ltd.. The generic name of Alobon Sanitizerspray is sanitizer spray. The product's dosage form is spray and is administered via topical form.

Labeler Name: Shantou Wanbang Cosmetic Co., Ltd.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Alobon Sanitizerspray 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 75 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • CHLOROXYLENOL (UNII: 0F32U78V2Q)

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: Shantou Wanbang Cosmetic Co., Ltd.
Labeler Code: 78692
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: 09-01-2020 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.

Alobon Sanitizerspray Product Label Images

Alobon Sanitizerspray 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

Alcohol 75%

Purpose

Antiseptic

Use

For decreasing bacteria on the skin

Warnings

  • For external use onlyFlammable, keep away from fire and flameDose not contain grain alcohol; do not drink. If taken internally will produce serious gastric disturbances.

When Using This Product

  • When using this productAviod the eyes and mucous membrancesIn the case of eyes and mucous membrances contact, rinse area thoroughly with water

Stop Use And Ask A Doctor If

  • Stop use and ask a doctor ifCondition worsensRedness or irritation developsIf condition persists for more than 3 days

Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed contact a doctor or Poison Control Center immediately.

Directions

  • Place enough Product in your palm to cover hands and rub hands together briskyly until dry.Supervise children in the use of this product.In the case of eye contact, rinse eyes thoroughly with water.

Other Information

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

Inactive Ingredients

Ammonium acryloyldimethyltaurate/vp copolymer, chloroxylenol, glycerin, methyl gluceth-10, water.

* Please review the disclaimer below.