BODY PRESCRIPTIONS FRENCH LAVENDER ANTIBACTERIAL HAND SANITIZER- 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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50563-416/JAS21AS1

Active Ingredient

Alcohol Denat: 75%

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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Directions

Wet hands thoroughly with product and allow to dry without wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other information

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water, Fragrance, Red 33, Blue 1

image description

BODY PRESCRIPTIONS FRENCH LAVENDER ANTIBACTERIAL HAND SANITIZER 
ethyl alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-416
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
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-416-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/25/2021
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(50563-416)

Revised: 3/2021
Document Id: be734917-bf14-4c32-e053-2a95a90a5a94
Set id: 9b128a0f-6ad9-49b1-8664-140813cd31bb
Version: 1
Effective Time: 20210326
 
ENCHANTE ACCESSORIES INC.