SPL v1
SPL
SPL Set ID b57ef0ef-809b-760a-e053-2995a90a88d2
Route
TOPICAL
Published
Effective Date 2020-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (72 L)
Inactive Ingredients
Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%) Water Aloe Vera Leaf Polyethylene Glycol 300

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-02

Description

Ethyl alcohol 72% v/v

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 72% v/v

Use

Hand sanitizer to help decrease bacteria on the skin.

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 appears and lasts.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eye thoroughly with water.

Section 51945-4

PRODUCT CODE

705555

STORE BETWEEN 33 TO 110F

MADA GEL 70% ALCOHOL

QUANTITY AND SIZE:

55 GALLON DRUM

MANUFACTURED FOR:

MADA MEDICAL PRODUCTS, INC.

625 WASHINGTON AVENUE

CARLSTADT, NEW JERSEY 07072

MADE IN USA

LOT NUMBER:

EXP:

Rev:12/20

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions
  • If hands are visibly soiled, wash with soap and water then dry hands.
  • Wet hands thoroughly with product, especially under the fingernails and allow to dry without rinsing.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl alcohol 72% v/v

Other Information
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Unactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf Juice.


Structured Label Content

Use (USE)

Hand sanitizer to help decrease bacteria on the skin.

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 appears and lasts.

Section 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eye thoroughly with water.

Section 51945-4 (51945-4)

PRODUCT CODE

705555

STORE BETWEEN 33 TO 110F

MADA GEL 70% ALCOHOL

QUANTITY AND SIZE:

55 GALLON DRUM

MANUFACTURED FOR:

MADA MEDICAL PRODUCTS, INC.

625 WASHINGTON AVENUE

CARLSTADT, NEW JERSEY 07072

MADE IN USA

LOT NUMBER:

EXP:

Rev:12/20

Purpose

Antiseptic

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Directions (DIRECTIONS)
  • If hands are visibly soiled, wash with soap and water then dry hands.
  • Wet hands thoroughly with product, especially under the fingernails and allow to dry without rinsing.
  • Children under 6 years of age should be supervised when using this product.
Active Ingredient

Ethyl alcohol 72% v/v

Other Information
  • Store below 110F (43C)
  • May discolor certain fabrics or surfaces
Unactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe Barbadensis Leaf Juice.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)