Instant Hand Sanitizer by Guangzhou Daieme Cosmetic Co., Ltd Instant Hand Sanitizer

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Daieme Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INSTANT HAND SANITIZER- instant hand sanitizer liquid 
Guangzhou Daieme Cosmetic 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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Instant Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 63.0%

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on skin.

Warnings

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

Do not use

do not use in or near the eves In case of contact rinse eyes thoroughly with wate

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

Stop use and ask docto if irritation or rash appears and lasts.

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

Stop use and ask docto if irritation or rash appears and lasts.

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

Directions

• Place enough product on your palm to thoroughly spread on both hands and rub into the skin until dry.
• Children under 6 years of age should be Supervised when using this product

Other information

• Store below 106°F(41°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water, acrylate/C10-30 alkyl acrylete crosspolymer, benzophenone-4, fragrance, glycein, tocopherol

Package Label - Principal Display Panel

INSTANT HAND SANITIZER 
instant hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75483-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SULISOBENZONE (UNII: 1W6L629B4K)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75483-006-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
2	NDC: 75483-006-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
3	NDC: 75483-006-06	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
4	NDC: 75483-006-04	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
5	NDC: 75483-006-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
6	NDC: 75483-006-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
7	NDC: 75483-006-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
8	NDC: 75483-006-08	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
9	NDC: 75483-006-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
10	NDC: 75483-006-10	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020
11	NDC: 75483-006-11	58 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/16/2020	01/21/2021

Labeler - Guangzhou Daieme Cosmetic Co., Ltd (418971601)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Daieme Cosmetic Co., Ltd		418971601	manufacture(75483-006)

Revised: 1/2021

Document Id: b9610c1c-6346-f477-e053-2a95a90ab4a9

34390-5

Set id: a84178ac-7783-20ba-e053-2995a90accee

Version: 3

Effective Time: 20210120