ADVANCED 2 IN 1 HAND SANITIZER- alcohol gel 
THE SUN CO.LTD

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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ACTIVE INGREDIENT

Alcohol 70.0%

INACTIVE INGREDIENTS

Water, Carbomer, Aminomethyl Propanol, Aloe Vera Gel, Grapefruit Seed Extract. Green Tea Extract, Butylene Glycol, Disodium EDTA, Phenoxyethanol

PURPOSE

Antiseptic

WARNINGS

For external use only. Flammable. Keep away from heat and 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 medical advice is needed, have the product container or label at hand.
■ If swallowed, get medical help or contact a Poison Control Center right away.

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.
■ For use when soap and water are not available.
■ Recommended for repeated use.

Directions

■ Place enough product on hands to cover all surfaces. Rub hands together until dry.
■ For children under 6, use only under adult supervision
■ Avoid direct inhalation of vapors during application (Headaches and irritation to mucous membranes may occur when directly inhaled.)
■ This product is intended only for hand sanitizing.
■ To prevent drying out and contamination, close the lid completely after use.
■ Keep in their original container not to cause accidents nor diminish the integrity of the product.
■ Do not use over bandages, castings, etc. ad irritation may occur.

Other Information

Other Information

■ Store below 43°C (110°F)
■ May discolor certain fabrics or surfaces

QUESTIONS

www.onnaturalusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

ADVANCED 2 IN 1 HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74923-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) Alcohol350 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AminomethylPropanol (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
Butylene Glycol (UNII: 3XUS85K0RA)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74923-100-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - THE SUN CO.LTD (694433104)
Registrant - THE SUN CO.LTD (694433104)
Establishment
NameAddressID/FEIBusiness Operations
THE SUN CO.LTD694433104manufacture(74923-100)

Revised: 6/2020
Document Id: 90b7c1af-b413-4e5b-8968-1398701e5101
Set id: 7364a7e4-96c3-44a7-b099-e01d83cdaf69
Version: 2
Effective Time: 20200604
 
THE SUN CO.LTD