CLEAN TO CLEAN HAND SANITIZER: Package Insert and Label Information

CLEAN TO CLEAN HAND SANITIZER- alcohol gel
LTP Global

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.

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

  • to decrease bacteria on the skin that could cause disease

Warnings

For external use only : hands

Flammable. Keep away from heat or flame.

  • When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • avoid contact with broken skin
  • do not inhale or ingest

Stop use and ask a doctor if

  • irritation and rash occurs. These may be signs of serious condition

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

Directions

  • Put enough product in your palm to cover hands and rub hands together briskly until dry
  • Children under 6 years should be supervised when using this product

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
  • Do not use on children under two months of age.

Inactive ingredients

Water, Carbomer, Tromethamin, Glycerin, Propylene Glycol, Panthenol, Aloe Barbadensis Leaf, Sodium Hyalunate, Tocopheryl Acetate

Package Label — Principal Display Panel

2mL Lable
(click image for full-size original)
Outbox
(click image for full-size original)

CLEAN TO CLEAN HAND SANITIZER
hand sanitizer gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73812-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
ALPHA-TOCOPHEROL ACETATE
ALOE VERA LEAF
TROMETHAMINE
PROPYLENE GLYCOL
GLYCERIN
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
WATER
PANTHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73812-003-02 100 POUCH in 1 BOX contains a POUCH (73812-003-03)
1 NDC:73812-003-03 2 mL in 1 POUCH This package is contained within the BOX (73812-003-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/29/2020
Labeler — LTP Global (694215916)
Establishment
Name Address ID/FEI Operations
KOREA COSPACK CO.,LTD. 689059789 manufacture (73812-003)

Revised: 05/2020 LTP Global

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