81276-016 1l Dongyang Medical

81276-016 1l Dongyang Medical
SPL v1
SPL
SPL Set ID b77e7039-94c7-a554-e053-2a95a90aaa83
Route
TOPICAL
Published
Effective Date 2020-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (750 mL)
Inactive Ingredients
Water

Identifiers & Packaging

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

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . 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 World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Purpose

Efficacy: Efficient to kill Staphylococcus aureus,Escherichia coil,Pseudo monas aeruginosa and Candida alibicans etc. Application: Hand disinfection and general object surface disinfection.


Medication Information

Purpose

Efficacy:

Efficient to kill Staphylococcus aureus,Escherichia coil,Pseudo monas aeruginosa and Candida alibicans etc.

Application:

Hand disinfection and general object surface disinfection.

Description

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry . 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 World Health Organization (WHO) recommendations: Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerol (1.45% v/v). Hydrogen peroxide (0.125% v/v). Sterile distilled water or boiled cold water. The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Use

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

Section 42229-5

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

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 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

1.EXTREMELY FLAMMABLE:

seal preservation, keep away from sunlight perpendicular incidence place and don't expose to temperatures exceeds 50℃.Don't pierce or burn, even after use. Don't spray on a naked flame or any flammable material. Keep it away from the reach of children. Don't spray towards eyes.

2.External disinfectant should not be taken orally and kept out of reach of children.

3.Use with caution if allergic to alcohol.

4.It should not be used to disinfect fat-soluble surfaces.

5.This product is irritating to wounds and mucous membranes.

Directions

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

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 50C (104F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic,Disinfection

Inactive Ingredients

purified water USP

Package Label Principal Display Panel

1L NDC: 81276-016-01


Structured Label Content

Use

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

Section 42229-5 (42229-5)

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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 World Health Organization (WHO) recommendations:

  • Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  • Glycerol (1.45% v/v).
  • Hydrogen peroxide (0.125% v/v).
  • Sterile distilled water or boiled cold water.

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 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

Efficacy:

Efficient to kill Staphylococcus aureus,Escherichia coil,Pseudo monas aeruginosa and Candida alibicans etc.

Application:

Hand disinfection and general object surface disinfection.

Warnings

1.EXTREMELY FLAMMABLE:

seal preservation, keep away from sunlight perpendicular incidence place and don't expose to temperatures exceeds 50℃.Don't pierce or burn, even after use. Don't spray on a naked flame or any flammable material. Keep it away from the reach of children. Don't spray towards eyes.

2.External disinfectant should not be taken orally and kept out of reach of children.

3.Use with caution if allergic to alcohol.

4.It should not be used to disinfect fat-soluble surfaces.

5.This product is irritating to wounds and mucous membranes.

Directions

1.Hand disinfection follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist.wait for 3 minutes,rub hands until dry.

2.General object surface disinfection directly spray on the object surface for until moist,wait for 3-5 minutes.

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 50C (104F)
Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic,Disinfection

Inactive Ingredients (Inactive ingredients)

purified water USP

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

1L NDC: 81276-016-01


Advanced Ingredient Data


Raw Label Data

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