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.

----------

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/01/2019

Labeler - Elemental Herbs, Inc. (132776357)