INSTA-SHIELD HAND SANITIZER GEL- alcohol gel

Insta-Shield by

Drug Labeling and Warnings

Insta-Shield by is a Otc medication manufactured, distributed, or labeled by FLORIDA HEMP LABS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient(s):

Alcohol (ethanol) 65%.

Purpose

Antiseptic

Use(s):

Helps reduce bacteria that can potentially become disease.

WARNING

For external use only. FLAMMABLE: Keep away from heat and flame.
Do NOT USE: On children less than 2 months of age.
Do NOT USE: On open skin wounds.
Keep out of eyes, ears, and mouth. Stop use if rash or irritation occurs. This could be a sign of a serious condition.

Keep out of reach of children. If swallowed contact doctor or poison control right away. 

Directions: 

Place enough product on hands to cover all surfaces, rub together until dry.
Supervise children under 6 years of age to prevent swallowing.

Other Information:

Store between 59-86°F. DO NOT store in heat above 105°F. May discolor some fabrics. Harmful to wood surfaces and plastics. 

Inactive ingredient(s): 

Glycerin, Aloe Barbadensis Leaf Juice, Hydroxyethylcellulose, Purified Water, Essential Oils

SPL UNCLASSIFIED SECTION

One Drop GEL

Alcohol Antiseptic 65%/Topical Solution

Produced & Bottled By Four Fathers Distillery
2917 Borden St., Jacksonville, FL 32209

MADE IN USA

FOUR FATHERS Distillery, Jacksonville, Florida
For questions, concerns or help please call the distillery at 904-710-615

Packaging

INGREDIENTS AND APPEARANCE

INSTA-SHIELD  HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78829-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
WATER (UNII: 059QF0KO0R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EUCALYPTUS OIL (UNII: 2R04ONI662)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78829-101-38	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/10/2020

Labeler - Four Fathers Distillery LLC (085564625)

Establishment
Name	Address	ID/FEI	Business Operations
Four Fathers Distillery LLC		085564625	manufacture(78829-101)