OTC Medication Information: Workforce Personal Care Hand Sanitizer Lemon Tea Tree

WORKFORCE PERSONAL CARE HAND SANITIZER LEMON TEA TREE- alcohol gel
Prima Fleur Botanicals, 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.

Directions for Use

Warnings

Inactive Ingredients

Use

Warnings:

Use

hand sanitizer to reduce bacteria on skin

Workforce Personal Care Hand Sanitizer Lemon Tea Tree

8oz Lemon Tea Tree Label

Lemon Tea Tree 16oz front label

Lemon Tea Tree 128oz (gallon) front label

WORKFORCE PERSONAL CARE HAND SANITIZER LEMON TEA TREE ethyl alcohol hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71824-7908 Route of Administration CUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 165.6116 mL in 236.588 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN PELARGONIUM GRAVEOLENS FLOWER OIL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) ANHYDROUS CITRIC ACID LITSEA CUBEBA FRUIT ORANGE OIL, DISTILLED LEPTOSPERMUM PETERSONII LEAF OIL ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71824-7908-1 1 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/21/2020

WORKFORCE PERSONAL CARE HAND SANITIZER LEMON TEA TREE ethyl alcohol hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71824-7916 Route of Administration CUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 331.2232 mL in 473.176 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN PELARGONIUM GRAVEOLENS FLOWER OIL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) ANHYDROUS CITRIC ACID LITSEA CUBEBA FRUIT ORANGE OIL, DISTILLED LEPTOSPERMUM PETERSONII LEAF OIL ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71824-7916-1 1 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/21/2020

WORKFORCE PERSONAL CARE HAND SANITIZER LEMON TEA TREE ethyl alcohol hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71824-7902 Route of Administration CUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 41.40297 mL in 59.1471 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN PELARGONIUM GRAVEOLENS FLOWER OIL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) ANHYDROUS CITRIC ACID LITSEA CUBEBA FRUIT ORANGE OIL, DISTILLED LEPTOSPERMUM PETERSONII LEAF OIL ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71824-7902-1 1 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/21/2020

WORKFORCE PERSONAL CARE HAND SANITIZER LEMON TEA TREE ethyl alcohol hand sanitizer gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71824-7900 Route of Administration CUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 2649.787 mL in 3785.41 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN PELARGONIUM GRAVEOLENS FLOWER OIL HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) ANHYDROUS CITRIC ACID LITSEA CUBEBA FRUIT ORANGE OIL, DISTILLED LEPTOSPERMUM PETERSONII LEAF OIL ALOE VERA LEAF

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71824-7900-1 1 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/21/2020

Labeler — Prima Fleur Botanicals, Inc. (825058308)

Registrant — Prima Fleur Botanicals, Inc. (825058308)

Establishment
Name	Address	ID/FEI	Operations
Prima Fleur Botanicals, Inc.		825058308	manufacture (71824-7908), manufacture (71824-7916), manufacture (71824-7902), manufacture (71824-7900)

Revised: 05/2020 Prima Fleur Botanicals, Inc.