HAND SANITIZER 01- hand sanitizer gel gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Yiwu Shining Cosmetics Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Purpose

Ethyl Alcohol 62%

PURPOSE

Antiseptic

INDICATIONS & USAGE

For handwashing to decrease bacteria on the skin

WARNINGS

Flammable, keep away from fire or flame.
For external use only.

Do not use near eyes.
In case of contact, flush eyes with water.

Stop use and ask a doctor
If redness or irritation develop and persist for more than 72 hours.

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

DO NOT USE

Do not use near eyes.
In case of contact, flush eyes with water.

WHEN USING

Do not use near eyes.
In case of contact, flush eyes with water.

Stop use and ask a doctor
If redness or irritation develop and persist for more than 72 hours.

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

STOP USE

Stop use and ask a doctor
If redness or irritation develop and persist for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Place a palmful (5 grams) of product in one hand.
Spread on both hands and rub into skin until dry (1-2 min.).
Place a smaller amount (2.5 grams) into one hand, spread overboth hands to wrist and rub into the skin until dry.
Children must be supervised in the use of this product

STORAGE AND HANDLING

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Inactive ingredients

Aloe Barbadensis Leaf Juice, Carbomar, Fragrance, Glycerin, Propylene Glycol, Triethanolamine.

PRINCIPAL DISPLAY PANEL

74862-008-01 29ml

74862-008-02 30ml

74862-008-03 59ml

74862-008-04 60ml

74862-008-05 100ml

74862-008-06 120ml

74862-008-07 180ml

74862-008-08 240ml

74862-008-09 300ml

74862-008-10 500ml

INGREDIENTS AND APPEARANCE

HAND SANITIZER  01
hand sanitizer gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74862-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74862-008-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
2	NDC: 74862-008-03	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
3	NDC: 74862-008-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
4	NDC: 74862-008-05	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
5	NDC: 74862-008-06	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
6	NDC: 74862-008-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
7	NDC: 74862-008-08	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
8	NDC: 74862-008-09	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
9	NDC: 74862-008-10	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020
10	NDC: 74862-008-07	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020

Labeler - Yiwu Shining Cosmetics Co.,Ltd (543002719)

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu Shining Cosmetics Co.,Ltd		543002719	manufacture(74862-008)