OCEAN BREEZE SCENTED HAND SANITIZER 01- alochol gel

ocean breeze scented hand sanitizer by

Drug Labeling and Warnings

ocean breeze scented 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

Alcohol Denat. 70%(v/v)..... Antibacterial

Use

To decrease bacteria on the skin that could cause disease.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

• Keep out of eyes.
• Avoid contact with broken skin.

Stop use and ask a doctor if

• Irritation or redness develops.

Keep out of reach of children

• Do not inhale or ingest
• if swallowed, get medical help or contact a poison control center right away.

Direction

Rub a dime sized drop into hands.

For children under 8 use under adult supervision

Inactive ingredients

WATER(AQUA/EAU), PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE( PARFUM), ACRYLATES/ C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE.
MAY CONTAIN: FD&C YELLOW NO. 5( CI19140), FD&C RED NO. 40( CI16035), FD&C BLUE NO.1(CI 42090), D&C RED NO. 33( CI 17200).

Questions?

1-212-779-0544 weekdays

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OCEAN BREEZE SCENTED HAND SANITIZER  01
alochol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74862-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0003 g  in 100 mL
WATER (UNII: 059QF0KO0R)	36.2397 g  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.0003 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.16 g  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	0.2 g  in 100 mL
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)	0.2 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)	0.2 mL  in 100 mL

Product Characteristics
Color	purple	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74862-004-01	59 mL in 1 BOTTLE, PLASTIC; 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)

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

Establishment
Name	Address	ID/FEI	Business Operations
Yiwu Shining Cosmetics Co.,Ltd		543002719	manufacture(74862-004)