PREMIUM HAND SANITIZER GEL PSG- alcohol gel 
Renowned Chemical Solutions Llc

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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RENOWNED Premium Gel Hand Sanitizer

Drug Facts

Active ingredient[s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

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

Warnings

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

Do not use

• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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.

Other Information

• Store between 15-30°C (59-86°F)

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

Inactive Ingredients glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, propylene glycol

Alcohol Antiseptic 70%

Topical Solution

Hand Sanitizer

Non-sterile Solution

Renowned Trading, LLC 18465 FM 362 RD, Waller, TX 77484

Packaging

IMAGE

PREMIUM HAND SANITIZER GEL  PSG
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74837-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74837-002-06500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/08/2020
Labeler - Renowned Chemical Solutions Llc (114392114)

Revised: 6/2020
Document Id: 34f16f21-47bc-4b28-8af3-d4eecf925f13
Set id: 24a925b8-92d8-4401-bfc5-d3e476451bac
Version: 1
Effective Time: 20200610
 
Renowned Chemical Solutions Llc