Miracle Brands Sense Dispense Hand Sanitizer by Miracle Brands Llc / Guangzhou Gotdya Fine Chemical Co., Ltd.

Miracle Brands Sense Dispense Hand Sanitizer by

Drug Labeling and Warnings

Miracle Brands Sense Dispense Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Miracle Brands Llc, Guangzhou Gotdya Fine Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MIRACLE BRANDS SENSE DISPENSE HAND SANITIZER- hand sanitizer gel 
Miracle Brands Llc

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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Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on skin.

Warnings

For external use only. Flammable. Keep away from fire or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

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 rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110F(43C)
• May discolor certain fabrics or surface

Inactive ingredients

Water, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance.

Package Label - Principal Display Panel

473 mL NDC: 80352-001-01

MIRACLE BRANDS SENSE DISPENSE HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80352-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80352-001-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020	12/31/2022

Labeler - Miracle Brands Llc (078282438)

Registrant - Miracle Brands Llc (078282438)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Gotdya Fine Chemical Co., Ltd.		551470189	manufacture(80352-001)

Revised: 12/2022

Document Id: f04e003a-27f0-f979-e053-2a95a90aa76c

34390-5

Set id: ae4c38c4-89f1-f289-e053-2a95a90a6dde

Version: 4

Effective Time: 20221220