HS- hand sanitizer spray spray 
Tropical Enterprises International, 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.

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Formula #LV/64-002 spray_ 70% ethyl alcohol hand sanitizer spray
Iceus formula

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose..... Antiseptic

INDICATIONS AND USAGE

Uses: Hand Sanitizer to reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

DOSAGE AND ADMINISTRATION

Directions: Wet hands thoroughly with product and allow to dry without wiping.

INACTIVE INGREDIENT

Inactive Ingredients Water, Carbomer, Triethanolamine

WARNING

WARNINGS: For external use only. When using this product avoid contact with eyes. If

contact with eyes occurs, flush with water.

Stop use and ask a doctor if irritation or redness develops and persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, seek prompt medical attention.

Flammable. Keep away from open flames.

Avoid freezing and excessive heat above 40C (104F)

Questions: 1-800-535-5053

Other Information: Non-staining, may discolor certain fabrics.

30ml

HS 
hand sanitizer spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL16.7 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRIETHYLAMINE (UNII: VOU728O6AY)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-156-0515 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
2NDC:58418-156-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
3NDC:58418-156-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
4NDC:58418-156-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
5NDC:58418-156-04120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
6NDC:58418-156-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
7NDC:58418-156-70211200 mL in 1 DRUM; Type 0: Not a Combination Product02/02/2020
8NDC:58418-156-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2020
9NDC:58418-156-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2020
10NDC:58418-156-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/02/2020
11NDC:58418-156-283840 mL in 1 JUG; Type 0: Not a Combination Product02/02/2020
12NDC:58418-156-321228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product02/02/2020
13NDC:58418-156-25960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2012
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)

Revised: 2/2020
Document Id: 9da4ec9a-4c0c-f000-e053-2995a90a69f0
Set id: 70ab7b6e-5a6e-7ab2-e053-2a91aa0ab9c8
Version: 2
Effective Time: 20200202
 
Tropical Enterprises International, Inc.