GOODEARTH- sanitizer gel gel

GoodEarth by

Drug Labeling and Warnings

GoodEarth by is a Otc medication manufactured, distributed, or labeled by GoodEarth Distribution LLC, Luoding Quality Amenities Supply Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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 and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using products.

Other information

Avoid freezing and excessive heat above 40C (104F)

May discolor certain fabrics or surfaces

Inactive ingredients

acrylates/C10-30 alky acrylate crosspolymer (55000 MPA.S) , aminomethyl propanol, glycerin, melaleuca alternifolia leaf oil, phenoxyethanol, water

Package Label - Principal Display Panel

300 mL NDC: 71745-128-01

INGREDIENTS AND APPEARANCE

GOODEARTH 
sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71745-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71745-128-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 71745-128-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 71745-128-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - GoodEarth Distribution LLC (079808558)

Establishment
Name	Address	ID/FEI	Business Operations
Luoding Quality Amenities Supply Limited		528126807	manufacture(71745-128)