SPL v3
SPL
SPL Set ID ae3d334f-66d7-49e3-b584-bebf1eae6ab4
Route
TOPICAL
Published
Effective Date 2021-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Isopropyl Myristate Alpha-tocopherol Acetate Caprylyl Glycol Aloe Vera Leaf Propylene Glycol Coco-caprylate Glyceryl Oleate Peg-7 Glyceryl Cocoate Peg-12 Dimethicone (300 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-10

Description

Ethyl Alcohol 75% V/V

Purpose

Antimicrobial.


Medication Information

Purpose

Antimicrobial.

Description

Ethyl Alcohol 75% V/V

Uses

Hand Sanitizer to help reduce bacteria on skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

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

Product Label

Active Ingredient

Ethyl Alcohol 75% V/V

Other Information

Store below 110°F (43°C).

May discolor certain fabrics or surfaces.

Inactive Ingredients

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

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.

Recommended for repeated use.

Purpose

Antimicrobial.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

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

Product Label (Product label)

Active Ingredient (Active ingredient)

Ethyl Alcohol 75% V/V

Other Information (Other information)

Store below 110°F (43°C).

May discolor certain fabrics or surfaces.

Inactive Ingredients (Inactive ingredients)

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate, PEG-12 Dimethicone (300 CST)

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)