Rinse Free Hand Wash

Rinse Free Hand Wash
SPL v1
SPL
SPL Set ID a44f9fac-bede-b27e-e053-2a95a90a0de8
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (1.45 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Hydroxypropyl Cellulose (90000 Wamw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

This is a Rinse free hand cleanser repackaged/labeled. 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 Center for Disease Control recommendations: Cleaning hands at key times with soap and water or hand sanitizer that contains at least 60% alcohol is one of the most important steps you can take to avoid getting sick and spreading germs to those around you. The firm does not add other active ingredients. Any additional ingredients added have been precisly measured and do not drop active ingredient below 62% Ethyl Alcohol, and does not impact the quality and potency of the product.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

This is a Rinse free hand cleanser repackaged/labeled. 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 Center for Disease Control recommendations: Cleaning hands at key times with soap and water or hand sanitizer that contains at least 60% alcohol is one of the most important steps you can take to avoid getting sick and spreading germs to those around you. The firm does not add other active ingredients. Any additional ingredients added have been precisly measured and do not drop active ingredient below 62% Ethyl Alcohol, and does not impact the quality and potency of the product.

Use

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

Section 42229-5

This is a Rinse free hand cleanser repackaged/labeled.

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 Center for Disease Control recommendations:

  • Cleaning hands at key times with soap and water or hand sanitizer that contains at least 60% alcohol is one of the most important steps you can take to avoid getting sick and spreading germs to those around you.

The firm does not add other active ingredients. Any additional ingredients added have been precisly measured and do not drop active ingredient below 62% Ethyl Alcohol, and does not impact the quality and potency of the product.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7

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.

Warnings

For external use only. Flammable. Keep away from heat or flame

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.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, Deionized Water, Propylene Glycol, Hydroxypropylcellulose, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate)

Package Label Principal Display Panel

118 mL NDC: 73909-0918-1

59 mL 73909-0918-2

Drug Facts label


Structured Label Content

Use

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

Section 42229-5 (42229-5)

This is a Rinse free hand cleanser repackaged/labeled.

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 Center for Disease Control recommendations:

  • Cleaning hands at key times with soap and water or hand sanitizer that contains at least 60% alcohol is one of the most important steps you can take to avoid getting sick and spreading germs to those around you.

The firm does not add other active ingredients. Any additional ingredients added have been precisly measured and do not drop active ingredient below 62% Ethyl Alcohol, and does not impact the quality and potency of the product.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 50567-7 (50567-7)

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.

Purpose

Antiseptic, Hand Sanitizer

Warnings

For external use only. Flammable. Keep away from heat or flame

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.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, Deionized Water, Propylene Glycol, Hydroxypropylcellulose, Lauryl Lactate, Myristyl Lactate, Cetyl Lactate, Organic Aloe Barbadensis (Aloe Vera) Leaf Extract, Panthenol (Pro-Vitamin B5), Tocopheryl Acetate (Vitamin E Acetate)

Package Label Principal Display Panel (Package Label - Principal Display Panel)

118 mL NDC: 73909-0918-1

59 mL 73909-0918-2

Drug Facts label


Advanced Ingredient Data


Raw Label Data

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