Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol gel
Giant Eagle

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 65%

Purpose

Antiseptic, Hand Sanitizer

Uses

For personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only.

  • Flammable.
  • Keep away from source of heat or fire.

When using this product

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Do not use

Do not use

  • On children less than 2 months of age
  • On open skin wounds
  • On broken or damaged skin.

Stop use and ask a doctor

Stop use and ask a doctor If irritation or redness develops and lasts.

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • For occasional and personal use.
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry.
  • Children under 6 years should be supervised when using this product.

Other information

  • Store at a temperature below 110ºF (43ºC).
  • May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), PEG-6, Fragrance, (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer.

Questions or comments?

1-866-695-3030

Package Label — Principal Display Panel

Hand Sanitizer 1oz
(click image for full-size original)

Package Label — Principal Display Panel

Hand Sanitizer 2oz
(click image for full-size original)

Package Label — Principal Display Panel

Hand Sanitizer with Pump 8oz
(click image for full-size original)

Pavkage Label — Principal Display Panel

Hand Sanitizer with Pump 32oz
(click image for full-size original)

HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56194-503
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 65 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
FRAGRANCE CLEAN ORC0600327
ISOPROPYL ALCOHOL
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%)
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
ISOPROPYL MYRISTATE
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56194-503-01 30 mL in 1 BOTTLE, PLASTIC None
2 NDC:56194-503-02 59 mL in 1 BOTTLE, PLASTIC None
3 NDC:56194-503-03 236 mL in 1 BOTTLE, PLASTIC None
4 NDC:56194-503-04 946 mL in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/01/2021
Labeler — Giant Eagle (929989007)
Registrant — Apollo Health and Beauty Care (201901209)
Establishment
Name Address ID/FEI Operations
Apollo Health and Beauty Care 201901209 manufacture (56194-503)

Revised: 01/2023 Giant Eagle

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