BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO PEPPERMINT SCENTED ALOE SCENTED- alcohol kit

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO Peppermint Scented Aloe Scented by

Drug Labeling and Warnings

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO Peppermint Scented Aloe Scented by is a Otc medication manufactured, distributed, or labeled by ENCHANTE ACCESSORIES INC., Xiamen Chengda Industrial Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Peppermint Scented

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Peppermint Scented

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

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ALOE SCENTED

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ALOE SCENTED

ACTIVE INGREDIENT

Active Ingredient

Alcohol Denat. 75%

PURPOSE

Purpose:

Antiseptic

INDICATIONS & USAGE

Uses:

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

Outer package

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Aloe Scented

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER Peppermint Scented

INGREDIENTS AND APPEARANCE

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER DUO PEPPERMINT SCENTED ALOE SCENTED 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50563-213

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-213-01	1 in 1 KIT	06/07/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30 mL
Part 2	1 BOTTLE	30 mL

Part 1 of 2

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER PEPPERMINT SCENTED 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-211
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-211-01	30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/07/2020

Part 2 of 2

BODY PRESCRIPTIONS ANTIBACTERIAL HAND SANITIZER ALOE SCENTED 
alcohol solution

Product Information
Item Code (Source)	NDC: 50563-212
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50563-212-01	30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/07/2020

Labeler - ENCHANTE ACCESSORIES INC. (186050696)

Establishment
Name	Address	ID/FEI	Business Operations
Xiamen Chengda Industrial Co.,Ltd		540042034	manufacture(50563-213)