75427-008 Scented Hand Sanitizer

Scented Hand Sanitizer by

Drug Labeling and Warnings

Scented Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jinhua City Wellmae Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SCENTED HAND SANITIZER- scented hand sanitizer gel 
Jinhua City Wellmae Cosmetics Co., Ltd.
Reference Label Set Id: a63aa00b-97c6-1fde-e053-2995a90a5960

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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75427-008
Scented Hand Sanitizer

ACTIVE INGREDIENT

Alcohol Denat.75% v/v

Purpose

Antiseptic

Hand sanitizer to help reduce bacteria on the skin that could cause disease.

For use when soap and water are not available.

WARNINGS

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

Keep out of eyes, ears,and mouth, ln case of contact with eyes, rinse eyes thoroughly with water.

Do not use

● ln children less than 2 months of age.
● On open skin wounds

Stop use and ask a doctor

● lf swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

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

Directions

● Place enough product in your palm to thoroughly cover your hands. Rub hands together briskly until dry.
● Children under 6 years of age should be supervised when using this product to avoid swallowing.

Other Information

● Store at 68°to 77℉ (20°~25℃)
● Do not store above 110℉ (43℃)
● You may report a serious adverse reaction to Centric Beauty LLC, 3505th Avenue, New York, NY 10118

Inactive Ingredients

Water, Glycerin,Fragrance, Acrylates/c10-30 Alkyl, Aminomethyl Propand, Blue 1, yellow 5, Red 28 , Red 40.

Package Label Principal Display Panel

SCENTED HAND SANITIZER 
scented hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75427-008
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
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75427-008-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
2	NDC: 75427-008-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020

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

Labeler - Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)

Registrant - Jinhua City Wellmae Cosmetics Co., Ltd. (543459963)

Establishment
Name	Address	ID/FEI	Business Operations
Jinhua City Wellmae Cosmetics Co., Ltd.		543459963	manufacture(75427-008)

Revised: 1/2022

Document Id: d5fe139e-c6b2-8602-e053-2995a90a0d74

34390-5

Set id: a9e61fc3-d3e5-4e8a-e053-2995a90af2b3

Version: 2

Effective Time: 20220120