Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8de94a9b-dac2-4150-88b4-5cea9f6595eb
Route
TOPICAL
Published
Effective Date 2020-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Glycerin Aloe Vera Leaf Peppermint Oil Tea Tree Oil Water Isopropyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-18

Description

Ethyl alcohol 80% v/v

Purpose

Antimicrobial


Medication Information

Purpose

Antimicrobial

Description

Ethyl alcohol 80% v/v

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable, keep away from fire or flame

For external use only

Directions
  • spray enough product on your palm to cover hands and rub hands together briskly until dry. 
  • children under 6 years of age should be supervised when using Papa Made.
Product Label

Active Ingredient

Ethyl alcohol 80% v/v

Other Information
  • Store below 1100C (430F). 
  • May discolor certain fabrics or surfaces
Inactive Ingredient

Water, Isopropyl Alcohol, Glycerol, Aloe vera, Peppermint oil, Tea tree oil

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria on the skin.

Purpose

Antimicrobial

Warnings

Flammable, keep away from fire or flame

For external use only

Directions
  • spray enough product on your palm to cover hands and rub hands together briskly until dry. 
  • children under 6 years of age should be supervised when using Papa Made.
Product Label

Active Ingredient (Active ingredient)

Ethyl alcohol 80% v/v

Other Information (Other information)
  • Store below 1100C (430F). 
  • May discolor certain fabrics or surfaces
Inactive Ingredient (Inactive ingredient)

Water, Isopropyl Alcohol, Glycerol, Aloe vera, Peppermint oil, Tea tree oil

When Using This Product (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 (Stop use and ask a doctor)

if irritation or rash appears and lasts

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

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)