42003-203

42003-203
SPL v2
SPL
SPL Set ID aedc1c58-db35-f9bb-e053-2995a90a7cff
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Cetylpyridinium Chloride Chamomile Phenoxyethanol Glycerin Ethylhexylglycerin Benzalkonium Chloride

Identifiers & Packaging

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

Description

Ethyl Alcohol 75% v/v

Purpose

Ethyl Alcohol Antiseptic


Medication Information

Purpose

Ethyl Alcohol Antiseptic

Description

Ethyl Alcohol 75% v/v

Use

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Section 50566-9

Stop use

Stop use and ask a doctor if irritation or rash occurs.

These maybe 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

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Warnings

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

Do not use

For children less than 2 months of age.

On open skin wounds.

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Directions

open the package lid and wipe skin until dry.

supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

Do not use

For children less than 2 months of age.

On open skin wounds.

Other Information

store between 15-30°C (59-86°F )

avoid freezing and excessive heat above 40°C (l04°F )

Sheet Size: 5.9" x 7.9" (15cm*20cm)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients

Cetylpyridinium chloride, Propylene Glycol, Phenoxyethanol, Benzalkonium, Glycerin, Ethylhexylglycerol, Water.

Package Label Principal Display Panel


Structured Label Content

Use

For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Section 50566-9 (50566-9)

Stop use

Stop use and ask a doctor if irritation or rash occurs.

These maybe 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

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Purpose

Ethyl Alcohol Antiseptic

Warnings

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

Do not use

For children less than 2 months of age.

On open skin wounds.

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or rash occurs.

These maybe signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center rig ht away.

Directions

open the package lid and wipe skin until dry.

supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

Do not use

For children less than 2 months of age.

On open skin wounds.

Other Information (Other information)

store between 15-30°C (59-86°F )

avoid freezing and excessive heat above 40°C (l04°F )

Sheet Size: 5.9" x 7.9" (15cm*20cm)

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Inactive Ingredients (Inactive ingredients)

Cetylpyridinium chloride, Propylene Glycol, Phenoxyethanol, Benzalkonium, Glycerin, Ethylhexylglycerol, Water.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)