Hand Sanitizer 63%- LLTT Gel

Hand Sanitizer 63% - LLTT by

Drug Labeling and Warnings

Hand Sanitizer 63% - LLTT by is a Otc medication manufactured, distributed, or labeled by Direct Packaged Ingredients (DPI), LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER 63% - LLTT- alcohol gel 
Direct Packaged Ingredients (DPI), 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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Hand Sanitizer 63%- LLTT Gel

Active Ingredient(s)

Alcohol 63% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

  • on 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 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.

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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, deionized water, carbomer, triethanolamine, lemon fragrance, lavender essential oil, tea tree essential oil

Package Label - Principal Display Panel

Small pump63% literHand Sanitizer 2 oz 2 oz (52 grams) NDC: 80656-101-02

HAND SANITIZER 63% - LLTT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80656-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK) 0.045 g  in 100 g
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95) 0.048 g  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.048 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.332 g  in 100 g
TEA TREE OIL (UNII: VIF565UC2G) 0.024 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 1.323 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.098 g  in 100 g
WATER (UNII: 059QF0KO0R) 38.082 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80656-101-013357 g in 1 JUG; Type 0: Not a Combination Product11/01/2020
2NDC: 80656-101-0252 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/01/2020
3NDC: 80656-101-03890 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/12/2020
4NDC: 80656-101-04420 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2020
5NDC: 80656-101-0652 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product03/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/01/202006/22/2023
Labeler - Direct Packaged Ingredients (DPI), LLC (557016024)
Establishment
NameAddressID/FEIBusiness Operations
Direct Packaged Ingredients (DPI), LLC557016024manufacture(80656-101)

Revised: 11/2021
Document Id: cffc1011-edc3-0362-e053-2995a90a0146
Set id: b07a79ee-1c9f-74cf-e053-2a95a90a11f3
Version: 8
Effective Time: 20211104