THYMES LEMON LEAF HAND SANITIZER- ethyl alcohol gel
Bell International Laboratories, 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.

----------

Thymes Lemon Leaf Hand Sanitizer

Active Ingredient

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use

To help reduce bacteria on the skin

Warnings

Flammable, keep away from heat and flame. For external use on the hands only. Avoid contact with eyes. If eye contact occurs, flush thoroughly with water. Avoid contact with broken skin. For Children under 6, use only under adult supervision.

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children. In case of accidental ingestion, seek medical assistance or contact a poison control center immediately.

Directions

Deposit a small amount in your palm and briskly rub hands together until dry.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Foeniculum Vulgare (Fennel) Seed Extract, Fragrance, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Melissa Officinalis Leaf Extract, PEG-40 Hydrogenated Castor Oil, Petroselinum Crispum (Parsley) Leaf Extract, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Symphytum Officinale Leaf Extract, Tocopherol, Trideceth-9, Water

266 mL/9.0 oz

266

54 mL/1.85 fl oz

THYMES LEMON LEAF HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76150-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
FENNEL SEED (UNII: G3QC02NIE6)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
COMFREY LEAF (UNII: DG4F8T839X)
TRIDECETH-9 (UNII: X9HD79I514)
PROPANEDIOL (UNII: 5965N8W85T)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PARSLEY (UNII: 58FMD0Q0EV)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
MANDARIN OIL (UNII: NJO720F72R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76150-338-71	266 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2021
2	NDC:76150-338-72	54 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	06/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/01/2021

Labeler - Bell International Laboratories, Inc (967781555)