Skin Cottage 70 Percent Ethyl Alcohol Antiseptic Hand Sanitizer: Package Insert and Label Information

SKIN COTTAGE 70 PERCENT ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER- alcohol gel
KEN-RICH CHEMICAL PRODUCTION SDN. BHD.

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.

Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.
Flammable, keep away from fire or flame.

Do not use

in the eyes.

Stop use and ask a doctor if:

  • Irritation and redness develop.
  • Condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Water, glycerin, propylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine.

Questions or Comments?

775-225-9908

Package Labeling:

Bottle
(click image for full-size original)

SKIN COTTAGE 70 PERCENT ETHYL ALCOHOL ANTISEPTIC HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:79468-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
TROLAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:79468-001-01 500 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 10/15/2020
Labeler — KEN-RICH CHEMICAL PRODUCTION SDN. BHD. (652207770)

Revised: 10/2020 KEN-RICH CHEMICAL PRODUCTION SDN. BHD.

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