SPL v2
SPL
SPL Set ID ccffe2a2-5284-2222-e053-2995a90afb1e
Route
TOPICAL
Published
Effective Date 2021-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Carbomer Homopolymer Type C Glycerin Water Isopropyl Myristate Trolamine .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-01-08

Description

Alcohol 70% v/v.


Medication Information

Description

Alcohol 70% v/v.

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 50565-1

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

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4

Section 55105-1

Purpose: Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 70% v/v.

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Water (aqua),Glycerin, Isopropyl Myristate, carbomer, Tocopheryl Acetate, Triethanolamine

Water, Glycerin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Glyceryl Caprylate, Glyceryl Caprate, Isopropyl Myristate, Aminomethyl Propanol, Caprylic/Capric Glycerides, Tocopherol, Benzophenone-4, Blue 1/ CL 42090, Yellow 5/ CL 19140


Structured Label Content

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Active Ingredient

Alcohol 70% v/v.

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Water (aqua),Glycerin, Isopropyl Myristate, carbomer, Tocopheryl Acetate, Triethanolamine

Water, Glycerin, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Glyceryl Caprylate, Glyceryl Caprate, Isopropyl Myristate, Aminomethyl Propanol, Caprylic/Capric Glycerides, Tocopherol, Benzophenone-4, Blue 1/ CL 42090, Yellow 5/ CL 19140


Advanced Ingredient Data


Raw Label Data

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