SHOFF HAND SANITIZER: Package Insert and Label Information

SHOFF HAND SANITIZER- alcohol gel
HIMMELGEISTER INC. dba HBA 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.

Drug Facts:

Active Ingredients

Ethyl Alcohol 70% V/V

Purpose

Antiseptic

Uses

  • hand sanitizer to decrease bacteria on the skin

Inactive Ingredients:

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, PARFUM, Tocopheryl Acetate(Vitamin E)

Directions:

  • Wet your hands thoroughly with the SHOFF Hand Sanitizer, rub until dry without wiping.
  • For children under6, use ONLY under adult supervision.
  • Not recommended for infants.

Warnings:

  • For external use only: hands
  • Flammable, keep away from fire or flame
  • Keep out of reach of children
  • Do not store above 100F(38C)
  • May discolor fabrics
  • Harmful to wood finishes and plastics

When using this product:

  • Keep out of eyes
  • In Case of contact of eyes, flush thoroughly with water
  • Avoid contact with broken skin
  • Do not inhale or ingest

Keep out of reach of children

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

Distributed by:

HBA Global.

Eastvale, CA 92880

Made in China

Item#: YZ669

860004093701

Quick-Antibacterial-Disinfection

KILLS MOST COMMON GERMS

MOISTURIZING

Packaging

IMAGE
(click image for full-size original)

SHOFF HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:78021-370
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
GLYCERIN
PROPYLENE GLYCOL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:78021-370-01 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/25/2020
Labeler — HIMMELGEISTER INC. dba HBA Global (076780561)

Revised: 05/2020 HIMMELGEISTER INC. dba HBA Global

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