47993-257

47993-257
SPL v2
SPL
SPL Set ID a55fdaf8-7997-5acf-e053-2995a90a2a52
Route
TOPICAL
Published
Effective Date 2020-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Aloe Vera Leaf Triethanolamine Benzoate Water Glycerin Carbomer 940

Identifiers & Packaging

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

Description

Active ingredients Alcohol 70% v/v


Medication Information

Warnings and Precautions

Warnings:

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

Indications and Usage

Uses:

To help reduce bacteria that could cause disease. Recommended for repeated use.

For use when soap and water is 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 Alcohol 70% v/v

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

  • On children less than 2 months of age.
  • In open skin wounds.
Section 51727-6

Inactive Ingredients:

Water,Carbomer,Triethanolamine,Glycerin,and Aloe Barbadensis Extract

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Alcohol 70% v/v

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:

To help reduce bacteria that could cause disease. Recommended for repeated use.

For use when soap and water is 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

  • On children less than 2 months of age.
  • In open skin wounds.
Section 51727-6 (51727-6)

Inactive Ingredients:

Water,Carbomer,Triethanolamine,Glycerin,and Aloe Barbadensis Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Alcohol 70% v/v

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)