TEEM HOGAR- alcohol gel 
Saniklyn, S. de R.L. de M.I

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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Alcohol 68% v/v. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

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

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

In 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 swallwed, get medical help or contact o Poison Control Center righ away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Store between 15-30C (59-86F)

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

Water USP, glycerin, triethalonamine and carbomer.

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.

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.

1000000 mL NDC: 79004-005-01 PDP 1000000

TEEM HOGAR 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79004-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 30.45 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.4 mL  in 100 mL
TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK) 0.4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.75 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79004-005-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/17/2020
Labeler - Saniklyn, S. de R.L. de M.I (816628069)
Establishment
NameAddressID/FEIBusiness Operations
Saniklyn, S. de R.L. de M.I.816628069manufacture(79004-005) , label(79004-005) , pack(79004-005)

Revised: 8/2020
Document Id: acc5529c-2ad9-6276-e053-2995a90a8a6f
Set id: acc5642e-2581-dcb1-e053-2a95a90a583b
Version: 1
Effective Time: 20200813
 
Saniklyn, S. de R.L. de M.I