SPL v2
SPL
SPL Set ID b5854abd-5cbf-4261-ab45-84eca4a2d207
Route
TOPICAL
Published
Effective Date 2020-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Carbomer Homopolymer, Unspecified Type Isopropyl Alcohol Aminomethylpropanol Panthenol Triisopropanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-11

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Use

Hand rub to help reduce bacteria that potentially can cause disease when water is not available.

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
Active Ingredient

Ethyl Alcohol 70%

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

Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine

Questions Or Comments

PGH Laboratorios do Brasil Ltda.

SAC (931) 444-6323

[email protected]

Principal Display Panel

NDC: 75751-070-04

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Net Wt. 120g e 4.2 oz

NDC: 75751-070-16

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 480g e 16.9 oz

NDC: 75751-070-26

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 1000L e 33814oz

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.


Structured Label Content

Use

Hand rub to help reduce bacteria that potentially can cause disease when water is not available.

Purpose

Antiseptic

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
Active Ingredient

Ethyl Alcohol 70%

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

Aqua, Carbomer, Isopropyl Alcohol, Aminomethyl Propanol, Panthenol, Triisopropanolamine

Questions Or Comments (Questions or Comments)

PGH Laboratorios do Brasil Ltda.

SAC (931) 444-6323

[email protected]

Principal Display Panel

NDC: 75751-070-04

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Net Wt. 120g e 4.2 oz

NDC: 75751-070-16

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 480g e 16.9 oz

NDC: 75751-070-26

Gel 70% (alcohol) - Read Instructions before use contains Hydrated Ethyl Alcohol 70 INPM

Gel 70% (alcohol)

Sanitation Effective against bacteria and germs

Requires no water

Danger: Flammable

Keep out of reach of children

Keep away from fire or flame

For external use only

See other cautions on opposite panel of label

Gel 70% (alcohol)

Net Wt. 1000L e 33814oz

When Using This Product (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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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