Prime Antibacterial Hand Sanitizer

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Drug Labeling and Warnings

Signature by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIGNATURE HAND SANITIZER- ethyl alcohol gel 
Prime Enterprises

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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Prime Antibacterial Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable

Flammable: Do not use near heat, flame or while smoking.

When using this product do not use in or near the eyes. In case of contact, rinse eyes throughly with water. Avoid contact with broken skin. Do not inhale or ingest.


Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Directions: Put enough product in your palm to cover hands and rub hands together briskly until dry.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

Other information

Store below 104ºF (40ºC).

Questions and comments Prime Enterprises 16363 NW 49th Avenue,Miami,Fl 33014

Prime Antibacterial Hand Sanitizer

Principle Display Label

SIGNATURE  HAND SANITIZER
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58443-0491
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL606.9 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58443-0491-5355 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/202004/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/29/202004/30/2022
Labeler - Prime Enterprises (101946028)
Registrant - Prime Enterprises (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises101946028manufacture(58443-0491) , analysis(58443-0491) , label(58443-0491) , pack(58443-0491)

Revised: 4/2022
 

Trademark Results [Signature]

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Trademark
Application Date
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