protex ndc: 77143-005

protex ndc: 77143-005
SPL v4
SPL
SPL Set ID a7abbdfe-3001-6a20-e053-2995a90ab952
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (0.5 mL)
Inactive Ingredients
glycerin carbomer 940 water trolamine edetic acid

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-03-30

Purpose

Antiseptic, Hand Sanitizer

Description

Alcohol 80% v/v. Purpose: Antiseptic


Medication Information

Warnings

Flammable, keep away from fire or flame.

For external use only.

Purpose

Antiseptic, Hand Sanitizer

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

Purified water USP, glycerin, carbomer, triethanolamine.

Description

Alcohol 80% v/v. Purpose: Antiseptic

Use

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

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.

Do Not Use

  • on open wounds
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

200000 mL NDC: 77143-005-01

3785 mL NDC: 77143-005-02

1000 mL NDC: 77143-005-03

500 mL NDC: 77143-005-04

19000 mL NDC: 77143-005-05

118 mL NDC: 77143-005-06

250 mL NDC: 77143-005-07

350 mL NDC: 77143-005-09


Structured Label Content

Warnings

Flammable, keep away from fire or flame.

For external use only.

Purpose

Antiseptic, Hand Sanitizer

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.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Purified water USP, glycerin, carbomer, triethanolamine.

Use

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

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.

Do Not Use (Do not use)

  • on open wounds
Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

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

200000 mL NDC: 77143-005-01

3785 mL NDC: 77143-005-02

1000 mL NDC: 77143-005-03

500 mL NDC: 77143-005-04

19000 mL NDC: 77143-005-05

118 mL NDC: 77143-005-06

250 mL NDC: 77143-005-07

350 mL NDC: 77143-005-09


Advanced Ingredient Data


Raw Label Data

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