NDC 71193-101 Hanna Hand Sanitizer Gel


NDC Product Code 71193-101

NDC 71193-101-01

Package Description: 500 mL in 1 BOTTLE

NDC 71193-101-02

Package Description: 300 mL in 1 BOTTLE

NDC Product Information

Hanna Hand Sanitizer Gel with NDC 71193-101 is a a human over the counter drug product labeled by Rainbow Beauty Cosmetic Co., Ltd.. The generic name of Hanna Hand Sanitizer Gel is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Rainbow Beauty Cosmetic 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.

Hanna Hand Sanitizer Gel 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.

  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • WATER (UNII: 059QF0KO0R)
  • D&C BLUE NO. 4 (UNII: 0KSY80VYS3)

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: Rainbow Beauty Cosmetic Co., Ltd.
Labeler Code: 71193
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: 09-03-2020 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.

Hanna Hand Sanitizer Gel Product Label Images

Hanna Hand Sanitizer Gel 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

Otc - Active Ingredient


Inactive Ingredient

Water, Glycerin, Carbomer, Triethanolamine, Fragrance, Camellia Sinensis Leaf Extract, Butylene Glycol, Aloe Barbadensis Leaf Extract, Portulaca Oleracea Extract, Centella Asiatica Extract, Pinus Densiflora Extract, CI 19140, CI 42090

Otc - Purpose

Sterilization of hands and skin

Otc - Keep Out Of Reach Of Children


Indications & Usage

Apply an appropriate amount on your hands and rub well to dry.


1. Do not use on the following body parts. A wide range of body parts and damaged skin around the eyes and

ears, in the oral cavity (may have irritating effects)

2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.

1) Hypersensitivity symptoms such as rash, erythema, itching, and edema

2) Skin irritation symptoms

3. Other precautions

1) For external use only (do not underwear).

2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.

3) Be careful not to inhale the vapor when using it extensively or for a long period of time (irritation to the

mucous membranes, headaches, etc. may occur if ethanol vapor is consumed in large quantities or repeatedly).

4) If repeated use on the same site, be careful as the skin may become rough due to degreasing.

5) Do not use sealed bandages, cast bandages, packs, etc., as irritation may occur.

6) Do not use this medicine for anal or vaginal compresses as it may cause irritation or chemical burns.

7) Do not use for any other purpose.

4. Precautions for storage

1) Avoid shading and keep in shading.

2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign


Dosage & Administration

For external use only

* Please review the disclaimer below.