SPL v2
SPL
SPL Set ID ad2adee4-e7b8-0fbc-e053-2995a90a5d71
Route
TOPICAL
Published
Effective Date 2020-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.62 mL)
Inactive Ingredients
Water Glycerin Aloe Vera Leaf Cucumber Banana Hedychium Coronarium Root Gardenia Taitensis Flower Coconut Oil Sea Salt Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-01

Description

Ethyl alcohol 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl alcohol 62%

Uses

to help reduce bacteria on the skin

recommended for repeated use

Warnings

For external use only

Flammable keep away from fire or flame

Directions
  • spray enough product in your palms to thoroughly cover your hands 
  • rub hands together briskly until dry
  • children under 6 years of age should be supervised when using this product
Questions?

1-877-978-6286

Active Ingredient

Ethyl alcohol 62%

Other Information
  • do not store above 104° F/40°C
  • may discolor some fabrics or surfaces
Package Labeling:

Inactive Ingredients

water,fragrance,glycerin,aloe barbadensis leaf juice, cucumis sativus (cucumber) fruit extract, musa sapientum (banana) fruit extract, hedychium coronarium root extract, gardenia taitensis flower extract, cocos nucifera (coconut) oil, sea salt, ethylhexylglycerin

When Using This Product

do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 

irritation or rash appears and lasts. Condition persists for more than 72 hours


Structured Label Content

Uses

to help reduce bacteria on the skin

recommended for repeated use

Purpose

Antiseptic

Warnings

For external use only

Flammable keep away from fire or flame

Directions
  • spray enough product in your palms to thoroughly cover your hands 
  • rub hands together briskly until dry
  • children under 6 years of age should be supervised when using this product
Questions?

1-877-978-6286

Active Ingredient (Active ingredient)

Ethyl alcohol 62%

Other Information (Other information)
  • do not store above 104° F/40°C
  • may discolor some fabrics or surfaces
Package Labeling:

Inactive Ingredients (Inactive ingredients)

water,fragrance,glycerin,aloe barbadensis leaf juice, cucumis sativus (cucumber) fruit extract, musa sapientum (banana) fruit extract, hedychium coronarium root extract, gardenia taitensis flower extract, cocos nucifera (coconut) oil, sea salt, ethylhexylglycerin

When Using This Product (When using this product)

do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

irritation or rash appears and lasts. Condition persists for more than 72 hours


Advanced Ingredient Data


Raw Label Data

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