ALOE VERA HAND SANITIZER- aloe vera hand sanitizer gel
Leadpro 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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1.Store below 15 30C (59 86F).
2.Avoid feezing and exessve heat above 40C (104F).

WATER

GLYCERIN

CARBOMER

TRIETHANOLAMINE

FRAGRANCE

1) FD&C RED NO.4 (CI14700)
2) FD&C YELLOW NO.5 (CI19140)
3) FD&C BLUE NO.1 (CI42090)
4) D&C RED NO.33 (CI17200)

1.Place enough poducton bonds to cover a sufare. Rub honds together unil dry.
2.Supervise Cildren under 6 years of age when using this produdt to avoid.

ALCOHOL

keep out of reach of children

Disinfection
Sterilization
No Rinseing

For external use only. Flammable. Keep away from heat or flame Do not use in cildren less than2 months of age .on open skin woundsWhen using this product keep out of eye,ears, and mouth. In case of contat with eyes, rinse thoroughly with water.
Stop use and ask a doctor if itationo or rash ocus. These moy be signs of a senious condition.Keep gut of reach of children. If sollowed, get medical help or contorl Poison Control Center right away.

label

ALOE VERA HAND SANITIZER
aloe vera hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41038-002
Route of Administration	EXTRACORPOREAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	307.45 mL in 473 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41038-002-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/29/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/29/2020

Labeler - Leadpro Inc. (041038367)

Name	Address	ID/FEI	Business Operations
Establishment
Leadpro Inc.		041038367	manufacture(41038-002)