WAIWAI GARDENIA HAND SANITIZER- ethyl alcohol gel

WAIWAI GARDENIA HAND SANITIZER by

Drug Labeling and Warnings

WAIWAI GARDENIA HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SRC Company Co., Ltd., C&N COSMETICS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol 70%

INACTIVE INGREDIENTS

Water, Carbomer, Glycerin, Propylene Glycol, Triethanolamine, Polysorbate 80, Fragrance

PURPOSE

ANTISEPTIC

WARNINGS

For external use only. Flammable. Keep away from heat or flame
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Do not use
in children less than 2 months of age
on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.
Recommended for repeated use.

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.
Not recommended for infants

Other Information

Store between 1℃-30℃ (33.8℉-86℉)
Avoid freezing and excessive heat above 40℃ (104℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WAIWAI GARDENIA HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78857-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	42 mL  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
Polysorbate 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78857-040-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2020

Labeler - SRC Company Co., Ltd. (694702525)

Registrant - SRC Company Co., Ltd. (694702525)

Establishment
Name	Address	ID/FEI	Business Operations
C&N COSMETICS CO.,LTD		688853696	manufacture(78857-040)