Imperial Palace-GoodEarth Alcohol wipes 250-250-60-800-800-30 PCS

GoodEarth by

Drug Labeling and Warnings

GoodEarth by is a Otc medication manufactured, distributed, or labeled by Imperial Palace Commodity (Shenzhen) Co., Ltd, Imperial Palace Commodity (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GOODEARTH- sanitizing wipes swab 
Imperial Palace Commodity (Shenzhen) Co., Ltd

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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Imperial Palace-GoodEarth Alcohol wipes 250-250-60-800-800-30 PCS

Active Ingredient(s)

Alcohol 75% v/v

Purpose

Antiseptic

Use

For sanitizing and to help reduce bacteria on the skin. 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 or near the eyes.
on open skin wounds or burns

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 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.

Directions

• Apply to hands and skin. No rinsing required. Discard after use.
• Children under 6 years of age should be supervised when using this product.

Other information

• Avoid freezing and store below 110F (43C).
• Dispose the used wipe in trash, do not flush it into the toilet.
• May discolor certain fabrics or surfaces.

Inactive ingredients

glycerin, water.

Package Label - Principal Display Panel

250 PCS NDC: 52489-125-01

GOODEARTH 
sanitizing wipes swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52489-125
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52489-125-01	250 in 1 CANISTER	06/20/2020	10/28/2020
1		250 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 52489-125-02	250 in 1 BAG	06/20/2020	10/28/2020
2		250 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 52489-125-03	60 in 1 POUCH	06/20/2020	10/28/2020
3		60 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 52489-125-04	30 in 1 POUCH	06/20/2020	10/28/2020
4		30 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 52489-125-05	800 in 1 CANISTER	06/20/2020	10/28/2020
5		800 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 52489-125-06	800 in 1 BAG	06/20/2020	10/28/2020
6		800 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 52489-125-07	80 in 1 BAG	06/20/2020	10/28/2020
7		80 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 52489-125-08	80 in 1 CANISTER	06/20/2020	10/28/2020
8		80 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 52489-125-09	100 in 1 BAG	06/20/2020	10/28/2020
9		100 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 52489-125-10	100 in 1 CANISTER	06/20/2020	10/28/2020
10		100 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
11	NDC: 52489-125-11	120 in 1 BAG	06/20/2020	10/28/2020
11		120 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/20/2020	10/28/2020

Labeler - Imperial Palace Commodity (Shenzhen) Co., Ltd (527796368)

Establishment
Name	Address	ID/FEI	Business Operations
Imperial Palace Commodity (Dongguan) Co., Ltd		544367643	manufacture(52489-125)

Revised: 9/2020

Document Id: af72971f-b384-6998-e053-2995a90a9f07

34390-5

Set id: a8be8472-e6ce-69bc-e053-2995a90acf63

Version: 6

Effective Time: 20200916

 

Imper