Xtra Care Hand sanitizer with vitamin E

HAND SANITIZER ANTIBACTERIAL VITAMIN E- ethyl alcohol liquid
China Ningbo Shangge Technology 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.

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Ethyl Alcohol 70.0% v/v

Antimicrobial

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

For external use only.

Flammable, keep away from fire or flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

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

Wet hands thoroughly with product
Briskly rub hands together until dry
Supervise children under 6 years in the use of this product

Other Information

store at room temperature
may discolor certain fabrics

water, glycerin, carbomer, fragrance, triethanolamine, propylene glycol, tocopheryl acetate, aloe barbadensis leaf juice

label 2 label

HAND SANITIZER ANTIBACTERIAL VITAMIN E
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58503-133
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58503-133-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/14/2020
2	NDC:58503-133-02	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/05/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/05/2020

Labeler - China Ningbo Shangge Technology Co., Ltd. (529287434)

Name	Address	ID/FEI	Business Operations
Establishment
China Ningbo Shangge Technology Co., Ltd.		529287434	manufacture(58503-133)