eco harbor HAND SANITIZING MIST ORANGE CITRUS by ENCHANTE ACCESSORIES INC. / Xiamen Wally Bath Manufacture Co., Ltd 50563-474/ PS3HSM04

eco harbor HAND SANITIZING MIST ORANGE CITRUS by

Drug Labeling and Warnings

eco harbor HAND SANITIZING MIST ORANGE CITRUS by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Wally Bath Manufacture Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO HARBOR HAND SANITIZING MIST ORANGE CITRUS- ethyl alcohol spray 
ENCHANTE ACCESSORIES INC.

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50563-474/ PS3HSM04

Active Ingredient

Ethyl Alcohol: 75% (W/W)

Purpose

Antiseptic

Use

■ To decrease bacteria on the skin that could cause disease
■Recommended for repeated use

WARNINGS

For external use only

Flammable. Keep away from heat and flame

When using this product, keep out of eyes
In case of contact with eyes, flush thoroughly with water

Avoid contact with broken skin

Do not inhale or ingest

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children.

For children under 6 years of age, use only under adult supervision

If swallowed, get medical help or contact a poison control center right away

Directions

Spray into palm and rub hands together

Allow to dry without wiping

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Fragrance, Aloe Barbadensis Leaf Extract, Citrus Aurantium (Orange) Oil, Citrus Aurantifolia (lime) Fruit Extract, Limonene, Linalool, Yellow 5, Red 4.

ECO HARBOR HAND SANITIZING MIST ORANGE CITRUS 
ethyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-474
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
LINALOOL, (+)- (UNII: F4VNO44C09)
CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-474-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2023	03/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/02/2023	03/17/2025

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Wally Bath Manufacture Co., Ltd		548232606	manufacture(50563-474)

Revised: 3/2025

Document Id: 30a55339-20b1-87b9-e063-6394a90aabd2

34390-5

Set id: 24bf3a87-2656-4eac-a52e-f164250e3b06

Version: 2

Effective Time: 20250318