DC0021TA(EN) ocean breeze/ blue zheng meng

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 ZHENG MENG COSMETICS CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OCEAN BREEZE SCENTED HAND SANITIZER 01- alochol gel 
ZHENG MENG COSMETICS 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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DC0021TA(EN) ocean breeze/ blue
zheng meng

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

OCEAN BREEZE SCENTED HAND SANITIZER  01
alochol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81220-002
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
TROLAMINE (UNII: 9O3K93S3TK)	0.16 g  in 100 mL
WATER (UNII: 059QF0KO0R)	36.2397 g  in 100 mL
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)	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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0003 g  in 100 mL

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81220-002-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/19/2020	05/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/19/2020	05/13/2021

Labeler - ZHENG MENG COSMETICS CO.,LTD. (659703591)

Registrant - ZHENG MENG COSMETICS CO.,LTD. (659703591)

Establishment
Name	Address	ID/FEI	Business Operations
ZHENG MENG COSMETICS CO.,LTD.		659703591	manufacture(81220-002)

Revised: 5/2021

Document Id: c2321607-7383-3a29-e053-2995a90af3a2

34390-5

Set id: bef96f6b-cfce-0e17-e053-2a95a90afada

Version: 2

Effective Time: 20210513