KLEAN KARE Hand Sanitizer: Package Insert and Label Information

KLEAN KARE HAND SANITIZER- alcohol gel
ALLEN-MEYER GROUP LLC

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% v/v.

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Reccomended for repeated use.

Warnings

Flammable. Keep away from heat or flame.

For external use only.

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

Directions

  • Place enough product on hands to thoroughly cover your hands. Rub hands together briskly until dry.
  • Children under 6 years of age should be supervised when using this product.

Other information

  • Store below 110 F (43C).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Isopropyl alcohol, Carbomer, Glycerin, Aminomethy Propanol.

Package Label — Principal Display Panel

Label 1500 mL

1500  m L
(click image for full-size original)

5000 mL

5000 mL
(click image for full-size original)
KLEAN KARE HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77205-001
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
WATER
ISOPROPYL ALCOHOL
AMINOMETHYLPROPANOL
GLYCERIN
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77205-001-01 1500 mL in 1 BOTTLE None
2 NDC:77205-001-02 5000 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/28/2020
Labeler — ALLEN-MEYER GROUP LLC (117509579)

Revised: 05/2020 ALLEN-MEYER GROUP LLC

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