PRIME Antibacterial Hand sanitizer

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 ADVANCED 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% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Flammable. do not use near heat, flame or while smoking.

When using this product do not use in or near the eyes. In cases of contact. rinse eyes thoroughly 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

• Put enough product in your palm to cover hands and rub hands together brisky until dry.

Other information

• Store below 104F(40C)

Inactive ingredients

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

PRIME ANTIBACTERIAL Hand Sanitizer

PRIME  ADVANCED HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0357
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	white (clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0357-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2020	11/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/18/2020	11/30/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0357) , analysis(58443-0357) , label(58443-0357) , pack(58443-0357)

Revised: 4/2022

Document Id: dbe9edaa-1a3c-6d36-e053-2a95a90ae9ad

34390-5

Set id: ae54cc23-47d0-4c40-e053-2a95a90a4932

Version: 2

Effective Time: 20220405