DEAD LIGHTNING - HAND SANITIZER- dead lightning - hand sanitizer liquid 
Dead Lightning Distillery, 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 Ingredients & Back Label

picActive ingredient[s]
Alcohol 80% v/v .................Antiseptic

Purpose Section

Use[s]
Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Indications and usage section

Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

Warnings section

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

Do not use section

Do not use
- in children less than 2 months of age
- on open skin wounds

When using section

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

Stop use section

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 section

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

Directions section

Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.

Dosage and Administration

Place enough product on hands to cover all surfaces. (Approx. 1/2 oz.) Rub hands together until dry.

Other safety information

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

Inactive ingredients section

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

Date of Production & Batch Number

Date of Production

Batch Number

Principal display panel & front label

PicDead Lightning Logo


HAND SANITIZER
Alcohol Antiseptic 80%
Topical Solution
WHO Recommended Hand Rub
Formulation #1
FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
NON-STERILE SOLUTION
NET WT.: 5 Gallons (18,926.06 ML)
Dead Lightning Distillery, LLC
233 Plum Street, Lemoyne, PA 17043
Made in USA

DEAD LIGHTNING - HAND SANITIZER 
dead lightning - hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75451-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL141.6 mL  in 177 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.23 mL  in 177 mL
WATER (UNII: 059QF0KO0R) 32.6 mL  in 177 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E) 2.57 mL  in 177 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75451-001-0118927.06 mL in 1 PAIL; Type 0: Not a Combination Product03/25/2020
2NDC:75451-001-027570.82 mL in 1 PAIL; Type 0: Not a Combination Product03/25/2020
3NDC:75451-001-037570.82 mL in 1 JUG; Type 0: Not a Combination Product03/25/2020
4NDC:75451-001-04709.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/25/2020
5NDC:75451-001-05739.34 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/25/2020
6NDC:75451-001-06177.44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2020
7NDC:75451-001-07236.59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/25/2020
Labeler - Dead Lightning Distillery, llc (928310072)
Registrant - Dead Lightning Distillery, llc (928310072)
Establishment
NameAddressID/FEIBusiness Operations
Dead Lightning Distillery, LLC928310072manufacture(75451-001)

Revised: 4/2020
Document Id: a1a73f32-a198-2540-e053-2a95a90a74bb
Set id: a1a73f32-a197-2540-e053-2a95a90a74bb
Version: 1
Effective Time: 20200421
 
Dead Lightning Distillery, llc