MASK ON EVERY FACE VITAMIN E ALOE HAND SANITIZER- alcohol gel
Taizhou Yadai Daily-Use 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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52989-004

Active Ingredient(s)

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help decrease 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 this product, keep out of eyes, ears or 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 serious condition.

Keep out of reach of children. If swallowed, get immediate medical help or contact a Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces
Rub hands together until dry
Supervise children under 6 years of age when using this product to avoid swallowing

Inactive ingredients

Water, Aminomethylpropanol, Carbomer 940, Aloe Vera Leaf, Alpha Tocopherol Acetate

image description

MASK ON EVERY FACE VITAMIN E ALOE HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52989-005
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52989-005-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
2	NDC:52989-005-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
3	NDC:52989-005-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
4	NDC:52989-005-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
5	NDC:52989-005-05	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
6	NDC:52989-005-06	53 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
7	NDC:52989-005-07	75 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
8	NDC:52989-005-08	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
9	NDC:52989-005-09	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020
10	NDC:52989-005-10	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/06/2020

Labeler - Taizhou Yadai Daily-Use Co., Ltd. (529899639)

Name	Address	ID/FEI	Business Operations
Establishment
Taizhou Yadai Daily-Use Co., Ltd.		529899639	manufacture(52989-005)