ORCHARD DE FLORE INSTANT HAND SANITIZER- alcohol gel
SONORA CORPORATION

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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Orchard De Flore Instant Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

• For hand sanitizing to decrease bacteria on the skin

• Recommended for repeated use

Warnings

For external use only

When using this product:

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if:

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Squeeze appropriate amount of sanitizer on to hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine.

Package Labeling:250ml

Label2

Package Labeling:500ml

Label3

ORCHARD DE FLORE INSTANT HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78733-015
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETOL (UNII: Q4R969U9FR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78733-015-00	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020
2	NDC:78733-015-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/28/2020

Labeler - SONORA CORPORATION (791913234)