LABCCIN Sanitizer Gel: Package Insert and Label Information

LABCCIN SANITIZER GEL- alcohol gel
Doori Cosmetics 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

Ethyl alcohol 70%

Purpose

Antimicrobial

Use

  • Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

Flammable. Keep away from fire or flame.

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Direction

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 below 15-30°C (59-86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, Butylene Glycol, Carbomer, Aminomethyl Propanol, Fragrance, Glycerin, Paeonia Suffruticosa Root Extract, Camellia Sinensis Leaf Extract, Aloe Ferox Leaf Extract, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT

Product Label
(click image for full-size original)

LABCCIN SANITIZER GEL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50375-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BUTYLENE GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
AMINOMETHYLPROPANOL
GLYCERIN
PAEONIA X SUFFRUTICOSA ROOT
GREEN TEA LEAF
ALOE FEROX LEAF
GRAPEFRUIT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50375-003-02 60 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 05/14/2020
Labeler — Doori Cosmetics Co., Ltd. (688227465)
Registrant — Doori Cosmetics Co., Ltd. (688227465)
Establishment
Name Address ID/FEI Operations
Doori Cosmetics Co., Ltd. 688227465 manufacture (50375-003)

Revised: 05/2020 Doori Cosmetics Co., Ltd.

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