Anti-bacterial Hand Sanitizer Blueberry: Package Insert and Label Information

ANTI-BACTERIAL HAND SANITIZER BLUEBERRY- alcohol gel
Buth-Na-Bodhaige, Inc.,

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.

Drugs Facts

Active Ingredient

Ethyl Alcohol (64.76%.)

Purpose

Antiseptic

Uses

  • Hand washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Avoid contact with broken skin.

Stop use and ask a doctor if irritation and redness develop or 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.
  • Children under 6 should be supervised when using this product.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Hydroxypropylcellulose, Fragrance, Propylene Glycol, Blue 1.

Questions?

Call 1-800-263-9746

PRINCIPAL DISPLAY PANEL — 75 ml Tube Label

THE
BODY
SHOP®

ANTI-BACTERIAL
HAND SANITIZER
BLUEBERRY

KILLS 99.9% OF MANY COMMON BACTERIA
ALCOHOL-BASED FORMULA
WITH A BLUEBERRY FRAGRANCE

75 ml (2.5 US FL OZ)

PRINCIPAL DISPLAY PANEL -- 75 ml Tube Label
(click image for full-size original)
ANTI-BACTERIAL HAND SANITIZER BLUEBERRY
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-372
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 64.76 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
Hydroxypropyl Cellulose, Unspecified
Trolamine
Propylene Glycol
FD&C Blue No. 1
Product Characteristics
Color BLUE (pale blue) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57691-372-75 75 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 05/10/2020
Labeler — Buth-Na-Bodhaige, Inc., (791071279)

Revised: 05/2020 Buth-Na-Bodhaige, Inc.,

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