HAND SANITIZER- alcohol gel 
KDX S A S

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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Hand Sanitizer

ACTIVE INGREDIENTS

Alcohol 70% v/v

PURPOSE

Antiseptic

USES

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 tan 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 sign.

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

Purified water USP, carbomer, triethanolamine

Package Labeling:

Bottle

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78647-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78647-000-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/15/2020
Labeler - KDX S A S (881144557)

Revised: 7/2020
Document Id: ab9a4605-a471-a993-e053-2995a90af5e8
Set id: ab9a3cba-95e2-2342-e053-2a95a90aac28
Version: 1
Effective Time: 20200729
 
KDX S A S