BARE HANDS- hand sanitizer spray
Bell International Labroatories, 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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Coola Bare Hands Hand Sanitizer Spray

Active Ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

to help reduce bacteria on the skin.

recommended for repeated use

Warnings

For external use only

Flammable. Keep away from fire/flame.

When using this product do not use in or near the eyes. In case of eye contact, rinse thoroughly with water.

Stop use and ask a dotor if irritaion or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Children under 6 years of age should be supervised.

Directions

Dispense an adequate amount in your hands and rub hands together until dry. Does not require rinising.

Other information

Do not store above 104 F (40 C). May discolor certain fabrics or surfaces.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Water

3.4 fl oz bottle label

BARE HANDS
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-239
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
CHAMOMILE (UNII: FGL3685T2X)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76150-239-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2020

Labeler - Bell International Labroatories, Inc. (967781555)