HAND SANITIZER- alcohol liquid 
GOOSE CREEK CANDLES, LLC

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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Gel Hand Sanitizer with aloe Moisturizes & Hydrates Skin 70% Alcohol. Hibiscus Fruit Punch

Active Ingredient

Alcohol 70%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

Do not eat or drink. Topical application only. Flammable. Keep away from fire or flame. For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor

Stop use and ask doctor if irritation or rash persists

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Put enough product in your palm to cover hands & rub together until dry. Children under 6 years of age should be supervised when using this product.

Other information

Store below 110 F (43C).

May discolor certain fabric surfaces

Inactive ingredient

Water/Aqua, Glycerin, Fragrance, Polysorbate 20, Carbomer, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice

Package Label

61354-077-01_aw

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82463-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL73.409 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.495 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 22.52 mL  in 100 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.49 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.98 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82463-077-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/16/2022
Labeler - GOOSE CREEK CANDLES, LLC (080086461)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(82463-077)

Revised: 8/2022
Document Id: e660b9cd-390f-a538-e053-2a95a90a8a78
Set id: e660bc4e-0e26-273f-e053-2995a90a1cbc
Version: 2
Effective Time: 20220816
 
GOOSE CREEK CANDLES, LLC