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

LABEL
(click image for full-size original)

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.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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