Hand Sanitizer: Package Insert and Label Information

HAND SANITIZER- alcohol liquid
Elemental Herbs, 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.

Active Ingredient(s)

Alcohol 62% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label — Principal Display Panel

All good organic peppermint
(click image for full-size original)
Thrive organic HS
(click image for full-size original)
2021 Update
(click image for full-size original)
Grove Hand Sanitizer Gel Blood Orange Back
(click image for full-size original)
Grove Hand Sanitizer Gel Blood Orange Front
(click image for full-size original)
All Good Organic Peppermint Spray 2 fl oz (REI)
(click image for full-size original)
All Good Peppermint Hand Sanitizer 2 fl oz (Thyme)
(click image for full-size original)
All Good Hand Sanitizer Gel 2 fl oz Unscented
(click image for full-size original)
All Good Peppermint Hand Sanitizer 2.0 fl oz
(click image for full-size original)
All Good Peppermint Hand Sanitizer 2.7 fl oz
(click image for full-size original)

HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-111
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
PROPANEDIOL
JOJOBA OIL
ALOE
ORANGE OIL
COCONUT OIL
SUNFLOWER OIL
.ALPHA.-TOCOPHEROL ACETATE
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
GLYCERIN
AMINOMETHYLPROPANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-111-61 59.1 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/11/2020
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-107
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
PEPPERMINT OIL
THYMUS VULGARIS LEAF
GLYCERIN
TOCOPHEROL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-107-59 60 mL in 1 BOTTLE, SPRAY None
2 NDC:75786-107-64 60 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/29/2020
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-102
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
TOCOPHEROL
PEPPERMINT OIL
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-102-55 80 mL in 1 BOTTLE, SPRAY None
2 NDC:75786-102-56 60 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/24/2020
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)
CITRIC ACID MONOHYDRATE
CALENDULA OFFICINALIS FLOWER
GLYCERIN
WATER
ALOE VERA LEAF
CHAMOMILE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-106-57 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/24/2020
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-108
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 60 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
TOCOPHEROL
THYMUS VULGARIS LEAF
PEPPERMINT OIL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-108-60 60 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/12/2020
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75786-112
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
GLYCERIN
TOCOPHEROL
THYMUS VULGARIS LEAF
PEPPERMINT OIL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75786-112-63 60 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/11/2022
Labeler — Elemental Herbs, Inc. (132776357)
Establishment
Name Address ID/FEI Operations
Evergreen Innovations LLC 024394560 manufacture (75786-102), manufacture (75786-106), manufacture (75786-107), manufacture (75786-108), manufacture (75786-111), manufacture (75786-112)

Revised: 05/2022 Elemental Herbs, Inc.

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