HAND SANITIZER- hand sanitizer gel 
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 #1000-B-Bulk gel - 70% ethyl alcohol hand sanitizer

ACTIVE INGREDIENT

Ethyl Alcohol 70% v/v

DOSAGE AND ADMINISTRATION

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

INACTIVE INGREDIENT

InActive Ingredients: Water, Carbomer, Triethanolamine

INDICATIONS AND USAGE

Use Hand Sanitizer to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

KEEP OUT OF REACH OF CHILDREN

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

OTC PURPOSE

Purpose... Antiseptic

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. If swallowed, seek prompt medical attention.

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

Flammable: Keep away from open flame.

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

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

30ml

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL20.4 mL  in 30 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 1342 (UNII: 809Y72KV36)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-116-0010 mL in 1 PACKET; Type 0: Not a Combination Product08/01/2012
2NDC:58418-116-0515 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
3NDC:58418-116-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/01/2012
4NDC:58418-116-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
5NDC:58418-116-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
6NDC:58418-116-04120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2012
7NDC:58418-116-08240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
8NDC:58418-116-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
9NDC:58418-116-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
10NDC:58418-116-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
11NDC:58418-116-28840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2012
12NDC:58418-116-70211200 mL in 1 DRUM; Type 0: Not a Combination Product02/02/2020
13NDC:58418-116-321228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product02/02/2020
14NDC:58418-116-1545 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
15NDC:58418-116-1852 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/02/2020
16NDC:58418-116-5530 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/01/2012
17NDC:58418-116-993840 mL in 1 JUG; Type 0: Not a Combination Product02/02/2020
18NDC:58418-116-09240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product01/02/2017
19NDC:58418-116-25960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/01/2020
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: 9da604db-9825-b2bc-e053-2a95a90a9646
Set id: 6e013ae7-955c-9d9c-e053-2991aa0a2767
Version: 5
Effective Time: 20200203
 
Tropical Enterprises International, Inc.