Prime Antibacterial Hand Sanitizer (cap)

Prime by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRIME 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 (cap)

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

PRIME  HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0489
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	609 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0489-9	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2020	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2020	05/31/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0489) , analysis(58443-0489) , label(58443-0489) , pack(58443-0489)

Revised: 4/2022

Document Id: dbe9e7e4-67cd-2dc8-e053-2995a90a12e5

34390-5

Set id: d2bbd150-c1b2-9427-e053-2a95a90abb83

Version: 2

Effective Time: 20220405