SPL v2
SPL
SPL Set ID d948e4a8-41f0-4a65-b7d6-3f8932c83f38
Route
TOPICAL
Published
Effective Date 2015-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Aloe Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-10

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses:
  • Cleansing gel for hands that need frequent care.
  • Decrease bacteria on skin.
  • Recommended for repeated use.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 51945-4

Principal Display Panel - 2 fl. oz. Label

Apple Scent

NEW CLEAR FORMULA

Monarch®

Hydrating Instant Hand Sanitizer

Cleansing gel for

hands that need frequent care.

Decreases bacteria on skin.

Enriched with Aloe Vera.

Leaves hands feeling

smooth and silky.

Order No. H6500-N (16 oz. Bottle)

Distributed By

AIR TECHNIQUES

equipped for life®

www.airtechniques.com

1295 Welt Whitman Road

Melville, NY 11747-3062

Net Contents:

2 fl. oz. / 60mL

Rev. A

Warnings:

For external use only. Flammable, keep away from fire or flame.

Directions
  • place a small amount into one hand
  • spread over both hands and wrist
  • rub into the skin until dry
  • do not wipe off; no rinsing required
Active Ingredient

Ethyl alcohol 66.5%

Other Information
  • store at 55° to 82°F
Inactive Ingredients

aloe vera, carbomer, fragrance, purified water, triethanolamine

When Using This Product
  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water
Stop Use and Ask Doctor If
  • irritation and redness develop and persists for more than 72 hours

Structured Label Content

Uses:
  • Cleansing gel for hands that need frequent care.
  • Decrease bacteria on skin.
  • Recommended for repeated use.
Section 42229-5 (42229-5)

Drug Facts

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 51945-4 (51945-4)

Principal Display Panel - 2 fl. oz. Label

Apple Scent

NEW CLEAR FORMULA

Monarch®

Hydrating Instant Hand Sanitizer

Cleansing gel for

hands that need frequent care.

Decreases bacteria on skin.

Enriched with Aloe Vera.

Leaves hands feeling

smooth and silky.

Order No. H6500-N (16 oz. Bottle)

Distributed By

AIR TECHNIQUES

equipped for life®

www.airtechniques.com

1295 Welt Whitman Road

Melville, NY 11747-3062

Net Contents:

2 fl. oz. / 60mL

Rev. A

Purpose

Antiseptic

Warnings:

For external use only. Flammable, keep away from fire or flame.

Directions
  • place a small amount into one hand
  • spread over both hands and wrist
  • rub into the skin until dry
  • do not wipe off; no rinsing required
Active Ingredient

Ethyl alcohol 66.5%

Other Information
  • store at 55° to 82°F
Inactive Ingredients

aloe vera, carbomer, fragrance, purified water, triethanolamine

When Using This Product (When using this product)
  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • irritation and redness develop and persists for more than 72 hours

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)