Hemirus Hand Clinic Gel 62%: Package Insert and Label Information

HEMIRUS HAND CLINIC GEL 62%- alcohol gel
GC US CORPORATION

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.

Alcohol 62%

Antiseptic

Uses

  • hand sanitizer to help decrease bacteria on the skin.
  • when water, soap & tower are not available
  • recommended for repeated use

Warnings

Flammable. Keep away from fire or flame

For external use only.

Do not apply around eyes. Do not use

in ears & mouth

When using this product

avoid contact with eyes.

In case of contact flush eyes with water

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions

  • pump as needed into your palms and throughly spread on both hands.
  • rub into skin until dry.

Other Information

  • Store at 20 o C (68 o to 77 o F).
  • may discolor fabrics.

Inactive Ingredients

Water, Phenoxyethanol, Trolamine, Carbomer homopolymer type C (Allyl pentaerythritol crosslinked)
Methylparaben, Orange, Isopropyl myristate, D&C Orange No. 4, Denatonium benzoate

Questions?

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Instant Hand Sanitizer!

Kills 99.9% of Most Common Germs!

Net Wt. 16.91 fl oz. (500ml)

Manufactured by Woosincosmetics Inc.

33, Sudo-ro, 125beon-gil, Bucheon-si,
Gyeonggi-do, Korea 14491

500mL NDC: 71454-3040-1

500 ml label
(click image for full-size original)

100mL NDC: 71454-3040-2

100 ml label
(click image for full-size original)

30mL NDC: 71454-3040-3

30 ml label
(click image for full-size original)
HEMIRUS HAND CLINIC GEL 62%
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71454-3040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.62 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PHENOXYETHANOL
TROLAMINE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
METHYLPARABEN
ORANGE
ISOPROPYL MYRISTATE
D&C ORANGE NO. 4
DENATONIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71454-3040-1 500 mL in 1 BOTTLE, PUMP None
2 NDC:71454-3040-2 100 mL in 1 TUBE None
3 NDC:71454-3040-3 30 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/31/2020
Labeler — GC US CORPORATION (080669481)
Establishment
Name Address ID/FEI Operations
WOOSIN COSMETICS CO.,LTD 688227829 manufacture (71454-3040)

Revised: 03/2020 GC US CORPORATION

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