Aurora Fresh Gel 71 Gel Hand Sanitizer With Vitamin E 1.7 Oz (50 Ml) Container

Aurora Fresh Gel 71 Gel Hand Sanitizer With Vitamin E 1.7 Oz (50 Ml) Container
SPL v1
SPL
SPL Set ID 35d52682-8004-4521-a81c-f4aca12d7ed6
Route
TOPICAL
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (70 L)
Inactive Ingredients
Water Hydroxypropyl Cellulose (1600000 Wamw) Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-03-24

Description

This is a gel hand sanitizer manufactured according to standard cGMP. 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 existing hand sanitizer products sold OTC throughout the United States and Globally: Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin (1.39% v/v). Hydroxymethyl Cellulose (0.7% v/v). Isopropyl Myristate (0.07% v/v) DL-Alpha-Tocopherol Acetate (0.07% v/v) Sterile distilled water (27.77% v/v). The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Purpose

Antiseptic / Hand Sanitizer


Medication Information

Purpose

Antiseptic / Hand Sanitizer

Description

This is a gel hand sanitizer manufactured according to standard cGMP. 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 existing hand sanitizer products sold OTC throughout the United States and Globally: Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin (1.39% v/v). Hydroxymethyl Cellulose (0.7% v/v). Isopropyl Myristate (0.07% v/v) DL-Alpha-Tocopherol Acetate (0.07% v/v) Sterile distilled water (27.77% v/v). The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use(s)

Hand Sanitizer to help reduce bacteria that potentially cause disease.

For use when soap and water are not available.

Section 42229-5

This is a gel hand sanitizer manufactured according to standard cGMP.

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 existing hand sanitizer products sold OTC throughout the United States and Globally:

Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin (1.39% v/v).

Hydroxymethyl Cellulose (0.7% v/v).

Isopropyl Myristate (0.07% v/v)

DL-Alpha-Tocopherol Acetate (0.07% v/v)

Sterile distilled water (27.77% v/v).

The firm does not add other active or inactive ingredients. Different or additional ingredients may 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 besigns 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 besigns 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 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

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Isopropyl Alcohol 70% 

Inactive Ingredients

deionized water, glycerin, hydroxypropyl cellulose, tocopheryl acetate, isopropyl myristate

Package Label Principal Display Panel

1.7 oz (50 mL) NDC: 77807-005-09


Structured Label Content

Use(s)

Hand Sanitizer to help reduce bacteria that potentially cause disease.

For use when soap and water are not available.

Section 42229-5 (42229-5)

This is a gel hand sanitizer manufactured according to standard cGMP.

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 existing hand sanitizer products sold OTC throughout the United States and Globally:

Isopropyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Glycerin (1.39% v/v).

Hydroxymethyl Cellulose (0.7% v/v).

Isopropyl Myristate (0.07% v/v)

DL-Alpha-Tocopherol Acetate (0.07% v/v)

Sterile distilled water (27.77% v/v).

The firm does not add other active or inactive ingredients. Different or additional ingredients may 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 besigns 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 besigns 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 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

Avoid freezing and excessive heat above 40C (104F)

Active Ingredient(s)

Isopropyl Alcohol 70% 

Inactive Ingredients (Inactive ingredients)

deionized water, glycerin, hydroxypropyl cellulose, tocopheryl acetate, isopropyl myristate

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

1.7 oz (50 mL) NDC: 77807-005-09


Advanced Ingredient Data


Raw Label Data

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