OTC Medication Information: XtraCare Instand Hand Sanitizer

XTRACARE INSTAND HAND SANITIZER- alcohol liquid
China Ningbo Shangge Cosmetic Technology Corp.

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.

PURPOSE

Antimicrobial

Active Ingredient

Ethyl Alcohol 70%

USAGE

For handwashing to decrease bacteria on the skin. Recommended for repeated use

Directions

Wet hands thoroughly with product

Briskly rub hands together until dry

supervise children under six years in the use of this product

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

Avoid contact with eyes. If this occurs, flush thoroughly with water.

Warnings

For external use only

Flammable keep away from heat and flame

Do not use in the eye. in case of contact rinse thoroughly with water.

Stop use and ask doctor if irritation and redness develops and persist for more than 72 hours

WATER, CARBOMER, TOCOPHEROL ACETATE, PROPYLENE GLYCOL, ALOE BARBADENSIS LEAF JUICE, TRIETHANOLAMINE, GLYCERIN

XTRACARE INSTAND HAND SANITIZER ethyl alcohol liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-090 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 70 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER GLYCERIN CARBOXYPOLYMETHYLENE TROLAMINE PROPYLENE GLYCOL ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58503-090-01 59 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/18/2017

Labeler — China Ningbo Shangge Cosmetic Technology Corp. (529287434)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture (58503-090)

Revised: 09/2019 China Ningbo Shangge Cosmetic Technology Corp.