MIRACLE HEALTH HAND SANITIZER- isopropyl alcohol gel
K W TECHNOLOGY 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.

----------

Active Ingredient

Isopropyl Alcohol 70% v/v.

Purpose

Antimicrobial

Use

Helps reduce bacteria and viruses on the skin that could cause disease. Recommended for repeated use. Do not ingest, for topical use only.

Warnings

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

Stop use and see doctor if irritation or rash appears/lasts.
When using this product do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

Keep out of reach of children. If swallowed get medical help or contact a poison control Center right away, not recommended for infants.

Directions

Place enough product in your palm to cover hands. Rub hand together until dry.
Children under 6years of age should be supervised when using this product.

Other information

Do not store above 110 F (43C).
May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Acrylates/C10 Alkyl Acrylate, Aloe Barbadensis Leaf Juice, Glycerin, Tocopherol Acetate, Lavendula Lalifolia, Triethanolamine

Package Label - Principal Display Panel

Label

MIRACLE HEALTH HAND SANITIZER
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79668-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVANDULA LATIFOLIA WHOLE (UNII: 45396ETX3Y)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:79668-001-01	60 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
2	NDC:79668-001-02	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
3	NDC:79668-001-03	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
4	NDC:79668-001-04	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
5	NDC:79668-001-05	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020
6	NDC:79668-001-06	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/16/2020

Labeler - K W TECHNOLOGY INC (129513852)