acb17917-fca1-6727-e053-2995a90a5968

SPL v1
SPL
SPL Set ID acb17917-fca1-6727-e053-2995a90a5968
Route
topical
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 L)
Inactive Ingredients
glycerin rapidgel ez1 water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-08-12

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v. Purpose: Antiseptic


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not ingest or inhale.

Purpose

Antiseptic

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

Fragrance (parfum), Glycerin, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoete Crosspolymer, Water

Description

Ethyl Alcohol 70% 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. Condition persists for more than 72 hours.

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.



Do Not Use
  • for children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

3.78L, NDC: 75594-006-08

.059L, NDC: 75594-006-01

.12L, NDC: 75594-006-02

.354L, NDC: 75594-006-04

.237L, NDC: 75594-006-03

.477L, NDC: 75594-006-05

.946L, NDC: 75594-006-06

1.89L, NDC: 75594-006-07


Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame. Do not ingest or inhale.

Purpose

Antiseptic

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)

Fragrance (parfum), Glycerin, PEG-6 (and) AMP-Acrylates/Vinyl Isodecanoete Crosspolymer, Water

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. Condition persists for more than 72 hours.

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.



Do Not Use (Do not use)
  • for children less than 2 months of age
  • on open skin wounds
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

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

3.78L, NDC: 75594-006-08

.059L, NDC: 75594-006-01

.12L, NDC: 75594-006-02

.354L, NDC: 75594-006-04

.237L, NDC: 75594-006-03

.477L, NDC: 75594-006-05

.946L, NDC: 75594-006-06

1.89L, NDC: 75594-006-07


Advanced Ingredient Data


Raw Label Data

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