ECO HARBOR HAND SANITIZING MIST EUCALYPTUS MINT- ethyl alcohol spray 
ENCHANTE ACCESSORIES INC.

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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50563-471/ PS3HSM01

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, Eucalyptus Globulus Leaf Extract, Mentha Arvensis Extract, Yellow 5, Blue 1.

image description

ECO HARBOR HAND SANITIZING MIST EUCALYPTUS MINT 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-471
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MENTHA ARVENSIS WHOLE (UNII: 46477RRB3O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-471-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/02/2023
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Wally Bath Manufacture Co., Ltd548232606manufacture(50563-471)

Revised: 6/2023
Document Id: fd20ec6b-113d-577d-e053-6294a90a27d3
Set id: f083fbb5-9e40-43f8-9fc0-60e011babdab
Version: 1
Effective Time: 20230602
 
ENCHANTE ACCESSORIES INC.