47993-275

47993-275
SPL v2
SPL
SPL Set ID a7ca644d-9f95-5033-e053-2995a90ac972
Route
TOPICAL
Published
Effective Date 2020-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Aloe Vera Leaf Water Glycerin Carbomer 940 Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-11

Description

Active ingredients Ethyl Alcohol 62%


Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration

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.
Description

Active ingredients Ethyl Alcohol 62%

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. These may be 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.

Section 50570-1

Do not use

in children less than 2 months of age

  • on open skin wounds
Section 51727-6

Inactive Ingredients:

Water,Glycerin,Carbomer,Triethanolamine,Aloe Barbadensis leaf juice.

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 62%

Section 60561-8

Other information

  • Store between 15-30℃(59-86℉)
  • Avoid freezing and excessive heat above 40℃(104℉)

Structured Label Content

Indications and Usage (34067-9)

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

Warnings:

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

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. These may be 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.

Section 50570-1 (50570-1)

Do not use

in children less than 2 months of age

  • on open skin wounds
Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Glycerin,Carbomer,Triethanolamine,Aloe Barbadensis leaf juice.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other information

  • Store between 15-30℃(59-86℉)
  • Avoid freezing and excessive heat above 40℃(104℉)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)