b5854abd-5cbf-4261-ab45-84eca4a2d207

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

Purpose

Antiseptic

Description

Ethyl Alcohol 70%


Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame

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

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

Description

Ethyl Alcohol 70%

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

Use

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

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 70%

Questions Or Comments

PGH Laboratorios do Brasil Ltda.

SAC (931) 444-6323

[email protected]

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

Warnings

For external use only. Flammable. Keep away from heat or flame

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)

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

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

Use

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

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

Ethyl Alcohol 70%

Questions Or Comments (Questions or Comments)

PGH Laboratorios do Brasil Ltda.

SAC (931) 444-6323

[email protected]

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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