XTREME PERSONAL CARE HAND SANITIZER- alcohol gel

XTREME Personal Care Hand Sanitizer by

Drug Labeling and Warnings

XTREME Personal Care Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Taizhou Yadai Daily-Use Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use

Hand sanitizer to help decrease bacteria on the skin

Warnings

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

When using this product, keep out of eyes, ears or mouth. In case of contact with eyes, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs, these may be signs of serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.

Directions

• Apply onto hands/skin, rub until dry

Inactive ingredients

Water, Triethanolamine, Carbomer, Aloe Barbadensis Leaf Juice, Glycerin, Frangrance, Propylene Glycol, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTREME PERSONAL CARE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52989-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52989-004-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
2	NDC: 52989-004-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
3	NDC: 52989-004-03	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020

Labeler - Taizhou Yadai Daily-Use Co., Ltd. (529899639)

Establishment
Name	Address	ID/FEI	Business Operations
Taizhou Yadai Daily-Use Co., Ltd.		529899639	manufacture(52989-004)