SPL v1
SPL
SPL Set ID a565484c-9ad5-4dad-e053-2995a90adc57
Route
TOPICAL
Published
Effective Date 2020-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 L)
Inactive Ingredients
Carbomer 940 Trolamine Water

Identifiers & Packaging

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

Description

Ethyl Alcohol 70% v/v


Medication Information

Warnings and Precautions

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

Indications and Usage

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and Administration
  • Wet hands thoroughly with product and rub into skin until dry.
  • Children under 6 years of age should be supervised when using this product.
Description

Ethyl Alcohol 70% v/v

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

and ask a doctor if irritation or rash occurs.

  • Condition persists for more than 72 hours.
Section 50567-7

keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid

contact with broken skin. Do not inhale or ingest.

Section 51727-6

Water, Carbomer, Triethanolamine.

Section 51945-4

Section 53413-1

Call: Risan Cosmetics +52 462 606 6070

Manufactured by Risan Cosmetics S.A. de C.V. Victorino de las Fuentes 487 Col. Barrio Nuevo P.C. 36530 Irapuato, Guanajuato, Mexico. Made in Mexico.

Section 55105-1

Antiseptic

Section 55106-9

Ethyl Alcohol 70% v/v

Section 60561-8

Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.


Structured Label Content

Indications and Usage (34067-9)

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Dosage and Administration (34068-7)
  • Wet hands thoroughly with product and rub into skin until dry.
  • Children under 6 years of age should be supervised when using this product.
Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

and ask a doctor if irritation or rash occurs.

  • Condition persists for more than 72 hours.
Section 50567-7 (50567-7)

keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid

contact with broken skin. Do not inhale or ingest.

Section 51727-6 (51727-6)

Water, Carbomer, Triethanolamine.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Call: Risan Cosmetics +52 462 606 6070

Manufactured by Risan Cosmetics S.A. de C.V. Victorino de las Fuentes 487 Col. Barrio Nuevo P.C. 36530 Irapuato, Guanajuato, Mexico. Made in Mexico.

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Ethyl Alcohol 70% v/v

Section 60561-8 (60561-8)

Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)