FOREVER HAND SANITIZER HAND SANITIZER- alcohol gel 
Aloe Vera of America, Inc.

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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Drug Facts for an OTC drug listing SPL for Forever Hand Sanitizer

Active Ingredients

Active ingredientPurpose
Ethyl Alcohol 62%Antimicrobial


Inactive Ingredients

Water (Aqua)

Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel)

Honey

Isopropyl Alcohol

Fragrance (Parfum)

Glycerin

Tetrahydroxypropyl

Ethylenediamine

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Tocopheryl Acetate
Isopropyl Myristate.

Purpose Section

Uses

  • hand sanitizer to decrease bacteria on the skin
  • recommended for repeated use

Warnings

Warnings

Fore external use only.

Flammable. Keep away from fire or flame.

Indications & Usage

  • do not use in or near the eyes. If contact occurs, rinse throughly with water.
  • avoid contact with broken skin.

Stop use and ask a doctor if

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration Directions

Directions

  • wet hands thoroughly with product
  • briskly rub hands together until dry
  • children under 6 years of age should be supervised when using this product

Other information

  • store at 20 °C to 25 °C (68°F to 77°F) when possible.  Do not store above 40 °C (104° F).
  • may discolor certain fabrics

Package Label Principal Display Panel

image of product labelLabel

FOREVER HAND SANITIZER  HAND SANITIZER
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL36.58 mL  in 59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HONEY (UNII: Y9H1V576FH)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETOL (UNII: Q4R969U9FR)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11697-318-0559 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/16/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/16/2010
Labeler - Aloe Vera of America, Inc. (049049463)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Pharmaceuticals Laboratories,LLC116933772manufacture(11697-318)

Revised: 12/2020
Document Id: b777f031-a6b3-5dba-e053-2995a90ad575
Set id: 296bea0a-c91c-28a4-e054-00144ff8d46c
Version: 8
Effective Time: 20201227
 
Aloe Vera of America, Inc.