Ecoriso Health Care Hand Sanitizer: Package Insert and Label Information

ECORISO HEALTH CARE HAND SANITIZER- alcohol gel
GM Holdings Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT

Ethyl Alcohol 76% v/v

INACTIVE INGREDIENTS

Water, Butylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Polyoxyethylene Hydrogenated Castor oil, Fragrance

PURPOSE

Antiseptic

WARNINGS

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

Do not use
• in children less than 2 months of age
• on open skin wounds

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.

KEEP OUT OF REACH OF CHILDREN

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

Uses:

Hand sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available

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.

Other information

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECORISO HEALTH CARE HAND SANITIZER ethyl alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69278-120 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 380 mL in 500 mL

Inactive Ingredients Ingredient Name Strength Water Butylene Glycol CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69278-120-01 500 mL in 1 BOTTLE, PUMP None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 06/01/2020

Labeler — GM Holdings Co., Ltd (688439958)

Registrant — GM Holdings Co., Ltd (688439958)

Establishment
Name	Address	ID/FEI	Operations
Ester Co., Ltd.		688425766	manufacture (69278-120)

Revised: 06/2020 GM Holdings Co., Ltd