Gel Hand Sanitizer with Aloe

Gel Hand Sanitizer with Aloe by

Drug Labeling and Warnings

Gel Hand Sanitizer with Aloe by is a Otc medication manufactured, distributed, or labeled by SALES AND PRODUCT SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GEL HAND SANITIZER WITH ALOE- ethanol 75% gel 
SALES AND PRODUCT SOLUTIONS

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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Gel Hand Sanitizer with Aloe

Active Ingredient

Ethanol 75%

Purpose

Antiseptic

Uses

To help reduce bacteria on the skin.

Warnings

FLAMMABLE. Keep away from heat or flame

For External Use Only.

When using this product

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

Do not use

Do not use with children less than 2 months of age

Supervise children under 6 years of age when using this product to avoid swallowing or getting in eyes and on face.

Do not use in open wounds or broken skin.

Stop use and ask a doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

Directions

Apply enough product on hands to cover all surfaces. Rub hands together until dry.

Inactive Ingredients

Water, Aloe Barbadensis Leaf Extract, Acrylates/C10-30 Alkylacrylate Crosspolymer, Triethanolamine, Tocopheryl Acetate, Glycerin, Jojoba Wax PEG-120Esters, Citral, Citronellol, Geraniol, Limonene, Linalool, Fragrance.

Other Information

Store between 59-86F (15-30C). -Avoid freezing and temperatures above 104 F (40C).

Gel Hand Sanitizer with Aloe

labellabel

GEL HAND SANITIZER WITH ALOE 
ethanol 75% gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37520-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL45 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
CITRAL (UNII: T7EU0O9VPP)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
CITRONELLOL ACETATE, (S)- (UNII: 78RZL4H51H)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37520-101-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC: 37520-101-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/202012/31/2022
Labeler - SALES AND PRODUCT SOLUTIONS (037519852)
Registrant - SALES AND PRODUCT SOLUTIONS (037519852)

Revised: 12/2022
Document Id: efcbd2e6-617c-ae05-e053-2a95a90a3e74
Set id: a75cee8b-13c6-2948-e053-2995a90a9e4b
Version: 3
Effective Time: 20221214