SURE SAFE HAND SANITIZER- alcohol gel 
Jab Holdings 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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Sure Safe Hand Sanitizer

DRUG FACTS:

Active Ingredient:

Ethyl Alcohol 75%

Purpose:

Antiseptic

USES:

• For hand sanitizing to decrease bacteria on the skin
• Recommended for repeated use

WARNINGS:

For external use only

When using this product:.

avoid contact with eyes. In case of eye contact, flush eyes with water

Stop use and ask a doctor if:

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical help or contact a poison control center right away.

DIRECTIONS:

Squeeze appropriate amount of sanitizer onto hands and rub together until dry. Use as needed. For children under 6, use with adult supervision. Not recommended for infants.

INACTIVE INGREDIENTS:

Water, Aloe Barnadensis Leaf Extract, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine

Package Labeling: 120ml

Label2

Package Labeling: 500ml

Label3

SURE SAFE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78111-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETOL (UNII: Q4R969U9FR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78111-010-00120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
2NDC:78111-010-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/14/2020
Labeler - Jab Holdings LLC (117502199)
Establishment
NameAddressID/FEIBusiness Operations
GUANGZHOU ORCHARD AROMATHERAPY & SKIN CARE CO.,LTD542355899manufacture(78111-010) , label(78111-010)

Revised: 5/2020
Document Id: a62d30d6-a51a-3c54-e053-2995a90a8bc0
Set id: 90ba321b-da97-4b2f-9125-e2679ae820df
Version: 2
Effective Time: 20200521
 
Jab Holdings LLC