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SPL v1
SPL
SPL Set ID 59a50110-89db-47f4-b626-dcb2b91f6ae6
Route
TOPICAL
Published
Effective Date 2020-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-15

Description

Ethyl alcohol 75% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 75% v/v

Uses
  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Section 42229-5

ANTISEPTIC HAND SANITIZER

Manufactured for: Beverly Pharmacy Inc, dba ZAP Hand Sanitizer, PO Box 3007, BH, CA 90212

COUNTRY OF ORIGIN: CHINA

Section 50565-1

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

Section 51727-6

Inactive ingredients    aloe vera, vitamin E

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product to avoid swallowing
Questions?

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Active Ingredient

Ethyl alcohol 75% v/v

Other Information
  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Structured Label Content

Uses
  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available
Section 42229-5 (42229-5)

ANTISEPTIC HAND SANITIZER

Manufactured for: Beverly Pharmacy Inc, dba ZAP Hand Sanitizer, PO Box 3007, BH, CA 90212

COUNTRY OF ORIGIN: CHINA

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 51727-6 (51727-6)

Inactive ingredients    aloe vera, vitamin E

Purpose

Antiseptic

Warnings

Flammable, keep away from fire/flame

For external use only

Do not use

• in children less than 2 months of age

• on open skin wounds

When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop

• condition persists for more than 72 hours

Packaging

Directions
  • wet hands thoroughly with product and allow to dry without wiping
  • supervise children under 6 years of age when using this product to avoid swallowing
Questions?

You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

Active Ingredient (Active ingredient)

Ethyl alcohol 75% v/v

Other Information (Other information)
  • store between 15-30°C (59-86°F)
  • avoid freezing and excessive heat above 40°C (104°F)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)