Miracle Brands Hand Sanitizer -alcohol free hand sanitizer liquid

Miracle Brands Hand Sanitizer by

Drug Labeling and Warnings

Miracle Brands Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kelly Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MIRACLE BRANDS HAND SANITIZER- alcohol free hand sanitizer liquid 
Kelly Products, 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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Miracle Brands Hand Sanitizer -alcohol free hand sanitizer liquid

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(s)

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Use

• For hand sanitizing to decrease bacteria on the skin.
• Recommend for repeated use.

Warnings

For external use only

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours

Directions

• spray a small amount of liquid into palm of hand
• rub thoroughly over all surfaces of both hands
• rub hands together briskly until dry

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, didecyldimonium chloride, propylene glycol, methylparaben, diazolidinyl urea, propylparaben, cocamidopropylamine, oxide, allantoin, cocamidopropyl betaine, cetrimonium chloride, triethanolamine, citric acid

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

Hand Sanitizing Liquid Spray

MIRACLE BRANDS HAND SANITIZER 
alcohol free hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79779-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
2,2'-((2-(DODECYLOXY)ETHYL)IMINO)BISETHANOL (UNII: 5MYL465X9V)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
ALLANTOIN (UNII: 344S277G0Z)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79779-001-04	118 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/19/2020
2	NDC: 79779-001-08	236 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/19/2020
3	NDC: 79779-001-01	3785 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/19/2020

Labeler - Kelly Products, Inc. (117590333)

Establishment
Name	Address	ID/FEI	Business Operations
Kelly Products, Inc.		117590333	manufacture(79779-001)

Revised: 1/2022

Document Id: d58e8113-87b6-6b76-e053-2a95a90a2a46

34390-5

Set id: ad2028c8-7a19-1a57-e053-2995a90a3dbd

Version: 3

Effective Time: 20220114