V FREE HAND SANITIZER: Package Insert and Label Information

V FREE HAND SANITIZER- alcohol gel
KUMSUNG ENC 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

Alcohol 70%

Purpose

Antiseptic

USE

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

WARNINGS

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

Do not use

– on infants less 2months of age

– on open skin wounds

When using this product

keep away from 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.

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 1~30℃(33.8~86℉)

– Avoid freezing and excessive heat above 40℃(104℉)

INACTIVE INGREDIENTS

glycerin, 1,3-butylene glycol, carbomer940, triethanol amine, purified water USP

Package Label

200ml NDC: 80138-202-01 Label
(click image for full-size original)

500ml NDC: 80138-202-02 Label
(click image for full-size original)
V FREE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:80138-202
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL
TROLAMINE
WATER
GLYCERIN
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80138-202-01 200 mL in 1 BOTTLE None
2 NDC:80138-202-02 500 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 part333A 08/25/2020
Labeler — KUMSUNG ENC CO., LTD (688082226)
Registrant — KUMSUNG ENC CO., LTD (688082226)
Establishment
Name Address ID/FEI Operations
KUMSUNG ENC CO., LTD 688082226 manufacture (80138-202)

Revised: 08/2020 KUMSUNG ENC CO., LTD

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