SPL v2
SPL
SPL Set ID a4730626-3124-662d-e053-2a95a90a0c1f
Route
TOPICAL
Published
Effective Date 2020-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.37263 g)
Inactive Ingredients
Glycerin Aloe Vera Leaf Water Caprylyl Glycol Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Isopropyl Myristate .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-25

Description

Hand sanitizer to help reduce bacteria on the skin

Purpose

Hand sanitizer to help reduce bacteria on the skin


Medication Information

Purpose

Hand sanitizer to help reduce bacteria on the skin

Description

Hand sanitizer to help reduce bacteria on the skin

Use

hand sanitizer to help reduce bacteria on the skin

Section 43683-2

Initial issue

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 with eyes, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts..



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

Warnings

Flammable. Keep away from heat or flame.

For external use only.

Directions
  • Put enought product in your palm to cover all surfaces of both hands and rub hands together briskly until dry.
  • children under 6 years of age should be supervised when using this product.
Other Information
  • Store below 110F
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Aloe Vera Leaf Juice (Organic), Ammonium Polyacryloyl Dimethyl Taurate, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl Myristate, Tocopheryl Acetate (Vitamin E), Water (Aqua)

Package Label Principal Display Panel


Structured Label Content

Use

hand sanitizer to help reduce bacteria on the skin

Section 43683-2 (43683-2)

Initial issue

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 with eyes, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash appears and lasts..



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

Purpose

Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from heat or flame.

For external use only.

Directions
  • Put enought product in your palm to cover all surfaces of both hands and rub hands together briskly until dry.
  • children under 6 years of age should be supervised when using this product.
Other Information (Other information)
  • Store below 110F
Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Aloe Vera Leaf Juice (Organic), Ammonium Polyacryloyl Dimethyl Taurate, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl Myristate, Tocopheryl Acetate (Vitamin E), Water (Aqua)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)