BODY PRESCRIPTIONS HAND SANITIZER WITH ALOE VERA- ethyl alcohol gel 
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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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, Hands

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

Stop use and ask a doctor if skin irritation develops

keep out of reach of children

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, Glycerin, PEG-40 Hydrogenated castor oil, Carbomer, Fragrance, Triethanolamine, Tocopheryl Acetate, Aloe barbadensis leaf extract, Blue 1, Yellow 5

image description

BODY PRESCRIPTIONS HAND SANITIZER WITH ALOE VERA 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50563-203
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 934 (UNII: Z135WT9208)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50563-203-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - ENCHANTE ACCESSORIES INC. (186050696)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Chengda Industrial Co.,Ltd540042034manufacture(50563-203)

Revised: 6/2020
Document Id: a70b8b91-0f72-4dc9-e053-2a95a90af8db
Set id: 260e1cc1-fa19-4850-bb28-f3b2e0cf83fe
Version: 1
Effective Time: 20200601
 
ENCHANTE ACCESSORIES INC.