SPL v3
SPL
SPL Set ID beb3ff90-f8de-00d1-e053-2a95a90a6fdb
Route
TOPICAL
Published
Effective Date 2021-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate Carbomer Homopolymer, Unspecified Type Caprylyl Glycol Aminomethylpropanol Aloe Vera Leaf Propylene Glycol Coco-caprylate Glyceryl Oleate Peg-7 Glyceryl Cocoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-11 Until 2021-03-11

Description

Ethyl alcohol 70% V/V

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl alcohol 70% V/V

Uses

Hand Sanitizer to help reduce bacteria on skin.

Section 51945-4

Warnings

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

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

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

Directions

   Put enough product in your palm to cover hands and rub hands together briskly until dry.

   Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

Drug Facts

Active Ingredient

Ethyl alcohol 70% V/V

Other Information

• Store below 110°F (430°C)

• May discolor certain fabrics or surfaces

Inactive Ingredients

Water, Aminomethylpropanol, Aloe Vera Leaf, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Alpha.-Tocopherol Acetate , Carbomer Homopolymer , Caprylyl Glycol, Coco Caprylate. Glyceryl Oleate, PEG-7 Glyceryl Cocoate, Propylene Glycol.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

Hand Sanitizer to help reduce bacteria on skin.

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Warnings

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

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

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

Directions

   Put enough product in your palm to cover hands and rub hands together briskly until dry.

   Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 70% V/V

Other Information (Other information)

• Store below 110°F (430°C)

• May discolor certain fabrics or surfaces

Inactive Ingredients (Inactive ingredients)

Water, Aminomethylpropanol, Aloe Vera Leaf, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Alpha.-Tocopherol Acetate , Carbomer Homopolymer , Caprylyl Glycol, Coco Caprylate. Glyceryl Oleate, PEG-7 Glyceryl Cocoate, Propylene Glycol.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)