SPL v2
SPL
SPL Set ID 76770197-6728-42f2-9833-42f02612c7b8
Route
TOPICAL
Published
Effective Date 2020-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Carbomer 940 Trolamine Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-14

Description

Ethyl Alcohol 75%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75%

Use

Hand sanitizer to help reduce potentially disease causing bacteria

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. This may be signs of serious condition

Do not use 

on children less than 2 months of age

on open skin wounds

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of eye contact with eyes, rinse eyes thoroughly with water.

Section 51945-4

Warnings

For external use only

Flammable. Keep away from heat or flame

Directions

Wet hands thoroughyl with product and allow to dry withour wiping

Other Information

May discolor some fabrics, harmful to wood finishes and plastics

Store between 59-68 F (15-30C)

Avoid freezing and excessive heat above 104F (40C)

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

Water, aloe barbadensis leaf jiuce, carbomer, triethanolamine


Structured Label Content

Use

Hand sanitizer to help reduce potentially disease causing bacteria

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. This may be signs of serious condition

Do not use 

on children less than 2 months of age

on open skin wounds

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of eye contact with eyes, rinse eyes thoroughly with water.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only

Flammable. Keep away from heat or flame

Directions

Wet hands thoroughyl with product and allow to dry withour wiping

Other Information (Other information)

May discolor some fabrics, harmful to wood finishes and plastics

Store between 59-68 F (15-30C)

Avoid freezing and excessive heat above 104F (40C)

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

Water, aloe barbadensis leaf jiuce, carbomer, triethanolamine


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)