Zhejiang Icolor Biotech Co., Ltd

Zhejiang Icolor Biotech Co., Ltd
SPL v2
SPL
SPL Set ID ab0866b5-11d3-317b-e053-2995a90aa0d9
Route
TOPICAL
Published
Effective Date 2020-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Denatonium Benzoate .alpha.-tocopherol Acetate Maltodextrin Aloe Vera Leaf Aminomethylpropanol Fragrance Lavender & Chia F-153480 Carbomer Interpolymer Type A (55000 Cps)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-22

Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic, Hand Sanitizer


Medication Information

Purpose

Antiseptic, Hand Sanitizer

Description

Ethyl Alcohol 70% v/v.

Use

Hand Sanitizer to help reduce germs on the skin.

Section 50565-1

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9

Stop using and ask a doctor if irritation or redness develops and lasts.

Section 50567-7

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Warnings
  • For external use only.
  • Flammable: Keep away from heat or flame.
Directions
  • Squeeze a significant amount in your palm and rub hands until fully dry.
  • Rinse free.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Other Information
  • Store below 110 °F(43° C).
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label Principal Display Panel

59 mL NDC: 74934-030-01

5000 mL NDC: 74934-030-03


Structured Label Content

Use

Hand Sanitizer to help reduce germs on the skin.

Section 50565-1 (50565-1)

Keep out of reach of children: ln case of accidental ingestion, get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor if irritation or redness develops and lasts.

Section 50567-7 (50567-7)

When using this product: avoid contact with eyes. lf contact occurs, rinse thoroughly with water.

Purpose

Antiseptic, Hand Sanitizer

Warnings
  • For external use only.
  • Flammable: Keep away from heat or flame.
Directions
  • Squeeze a significant amount in your palm and rub hands until fully dry.
  • Rinse free.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Other Information (Other information)
  • Store below 110 °F(43° C).
Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl propanol, Aloe Barbadensis leaf Juice, Denatonium benzoate, Fragrance, Glycerin, Maltodextrin, Propylene Glycol, Tocopheryl Acetate, Water.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

59 mL NDC: 74934-030-01

5000 mL NDC: 74934-030-03


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)