All Good - Grove Blood Orange Hand Sanitizer (02-EC-080)

Grove Blood Orange Hand Sanitizer by

Drug Labeling and Warnings

Grove Blood Orange Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Elemental Herbs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GROVE BLOOD ORANGE HAND SANITIZER- ethyl alcohol gel 
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.

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All Good - Grove Blood Orange Hand Sanitizer (02-EC-080)

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

Helps decrease bacteria on skin

Recommended for repeated use

Warnings

For external use only

Flammable: keep away from fire or flames

When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Stop use and ask doctor if irritation or redness develop and persist for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

Directions

Squeeze a small drop onto palms and rub together

For children under 6 years, use adult supervison

Not recommended for infants.

Inactive Ingredients

Water, Orange (Citrus Aurantium Dulcis) Oil, Glycerin, Propanediol, Carbomer, Aminomethyl Propanol, Aloe Vera (Aloe Barbadensis) Leaf Juice, Coconut (Cocos Nucifera) Oil, Sunflower (Helianthus Annuus) Seed Oil, Jojoba (Simmondsia Chinensis) Seed Oil, Tocopheryl Acetate

labels - 2 oz and 7.5 oz

GROVE BLOOD ORANGE HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75786-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
COCONUT OIL (UNII: Q9L0O73W7L)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ORANGE OIL (UNII: AKN3KSD11B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75786-237-41	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/01/2019
2	NDC: 75786-237-43	221.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2019

Labeler - Elemental Herbs, Inc. (132776357)

Revised: 6/2023

Document Id: ff5e7c82-5c95-86d2-e053-6294a90adae2

34390-5

Set id: fa6c1227-3816-7b2a-e053-6294a90a79b2

Version: 2

Effective Time: 20230630