HAND SANITIZER- alcohol gel 
Transformaciones Del Caribe, Sociedad Anonima

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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Instant Hand Sanitizer Anti bacterial

Uses

Uses

* Helps eliminated bacterias on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Active Ingredient

Active Ingredient Purpose

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if

* Irritation develops while using this product

Keep out of reach of children

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

Directions

Directions: Place enough product in your palm to throughly cover your hands.

Inactive Ingredients

water, carbomer, propylene glycol, triethanolamine

Questions?

QUESTIONS OR COMMENTS: Phone: (786) 871-6663

Uses

Uses

* Helps eliminated bacteria on hand. This product is not a substitute of soap hand washing. Avoid contact with broken and damaged skin

Hand Sanitizer Gel

Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78167-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
PROPANEDIOL (UNII: 5965N8W85T)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78167-008-017570.82 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2020
Labeler - Transformaciones Del Caribe, Sociedad Anonima (817531659)
Registrant - Transformaciones Del Caribe, Sociedad Anonima (817531659)
Establishment
NameAddressID/FEIBusiness Operations
Transformaciones Del Caribe, Sociedad Anonima817531659manufacture(78167-008)

Revised: 10/2020
Document Id: b1558431-f2d2-b9a4-e053-2995a90a9ea5
Set id: b15583e3-d25b-0711-e053-2a95a90a19b0
Version: 1
Effective Time: 20201010
 
Transformaciones Del Caribe, Sociedad Anonima