BRITTANIES THYME LAVENDER AND PEPPERMINT HAND SANITIZER- alcohol liquid
Gulf States International, 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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Brittanie’s Thyme Lavender and Peppermint Hand Sanitizer

DRUG FACTS

Organic Ethyl Alcohol 62%

Antiseptic

Uses:

To help reduce bacteria on the skin.

Warning

For External Use Only

Flammable, Keep away from fire or source of ignition.

When using this product,

keep out of eyes. In case of eye contact, flush thoroughly with water.

Stop use and ask a doctor

if irritation and redness develops and persists for more than 72 hours.

Keep out of reach of children.

If swallowed get medical attention or contact a poison control center immediately.

Other Information:

Store at room temperature 66°F to 77°F (20°C to 25°C) May discolor certain fabrics.

Directions:

Wet hands thoroughly and allow to air dry. For children under 6, use adult supervison. Not recommended for infants.

Inactive Ingredients:

Purified Water, *Aloe Leaf Juice, *Peppermint Oil, Lavender Oil, Glycerin and Vitamin E
*USDA Certified Organic

Package Labeling:

Bottle3

BRITTANIES THYME LAVENDER AND PEPPERMINT HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76473-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEPPERMINT OIL (UNII: AV092KU4JH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76473-103-01	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/21/2020

Labeler - Gulf States International, Inc (008156853)

Revised: 8/2022

Document Id: e572cb0a-bd97-a202-e053-2a95a90a78a3

Set id: c7d0866d-595f-415d-bebe-8e4d1338405e

Version: 2

Effective Time: 20220804

Gulf States International, Inc