Alcohol: Package Insert and Label Information

ALCOHOL- alcohol spray
ALCOHOL- alcohol gel
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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

Ethyl Alcohol — 62.0%

PURPOSE

Antiseptic

USES:

For hand washing to decrease bacteria on skin

• Recommended for repeated use.

WARNINGS:

For external use only

• Flammable
• Keep away from fire/flame

• Do not use this product in or near eyes. If contact occurs rinse thoroughly with water

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

DIRECTIONS:

Dispense an adequate amount in your palm to cover all surfaces of hands completely

• Rub hands together until dry
• Does not require rinsing.

OTHER INFORMATION:

Do not store above 104°F/40°C.

• May discolor some fabrics.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice. Chamomile Extract Carbomer, Glycerin, Natural Vitamin E (tocopheryl acetate), Panthenol, Propylene Glycol, Purified Water, Triethanolamine

Principal Display Panel – 118 mL Bottle Label

Non-sterile Solution

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Alcohol Antiseptic 80% Topical Solution

80% Alcohol

Hand Sanitizer Spray

4 fl. oz. (118 ml) e

Principal Display Panel – 354 mL Bottle Label

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Fragrance-Free

Kills Germs

Hand Sanitizer Gel

12 fl. oz. (354 ml) e

Principal Display Panel – 59 mL Bottle Label

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Fragrance-Free

Made with Aloe
and Chamomile Extracts.

Kills Germs

Hand Sanitizer Gel

2.0 fl. oz. (59 ml) e

ALCOHOL alcohol spray

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-039 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (Alcohol) Alcohol 80 mL in 100 mL

Inactive Ingredients Ingredient Name Strength Glycerin Hydrogen Peroxide Water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73418-039-01 118 mL in 1 BOTTLE None

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

ALCOHOL alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-040 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 Water Aloe Vera Leaf Glycerin CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73418-040-01 354 mL in 1 BOTTLE None

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

ALCOHOL alcohol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-041 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 Aloe Vera Leaf Chamomile CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE Glycerin .Alpha.-Tocopherol Acetate Panthenol Propylene Glycol Water TROLAMINE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73418-041-01 59 mL in 1 BOTTLE None

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

Labeler — Hello Bello (081135707)

Establishment
Name	Address	ID/FEI	Operations
Unconditional Love		081135707	MANUFACTURE (73418-039), MANUFACTURE (73418-040), MANUFACTURE (73418-041)

Revised: 02/2021 Hello Bello