PURELOGIC HAND SANITIZER SOOTHING GEL AND SOOTHING ALOE 6 PACK- alcohol kit

PureLogic Hand Sanitizer Soothing Gel and Soothing Aloe 6 Pack by

Drug Labeling and Warnings

PureLogic Hand Sanitizer Soothing Gel and Soothing Aloe 6 Pack by is a Otc medication manufactured, distributed, or labeled by Argento sc by sicura inc., Ningbo Roni Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PureLogic Hand Sanitizer Soothing Gel

PureLogic Hand Sanitizer Soothing Gel

Active Ingredient

Ethyl Alcohol 63%

Purpose

Antimicrobial

Use

■ Decrease bacteria on the skin that could cause diseases
■Recommended for repeated use

WARNINGS

For external use only, Hands

Flammable. Keep away from flame or fire

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 redness and irritation develop or if condition persistes for more than 72 hours

keep out of reach of children

Keep out of reach of children. If swalowed, get medical help or contact a poison control center immediately

Directions

Spread product on hands thoroughly and allow to dry, do not wipe off
For children under 6, use under adult supervision
Not recommended for use with infants

Other information

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to plastics and wood finishes

Inactive ingredients

Purified water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance

PureLogic Hand Sanitizer Soothing Soothing Aloe

PureLogic Hand Sanitizer Soothing Aloe

ACTIVE INGREDIENT

Active Ingredient

Ethyl Alcohol 63%

PURPOSE

Purpose:

Antimicrobial

INDICATIONS & USAGE

Uses:

Decrease bacteria on the skin that could cause diseases
■Recommended for repeated use

Warnings

For external use on hands only

Flammable. Keep away from flame or fire

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 redness and irritation develop or if condition persistes for more than 72 hours

Keep out of reach of children

Keep out of reach of children. If swalowed, get medical help or contact a poison control center immediately

Directions

Spread product on hands thoroughly and allow to dry, do not wipe off
For children under 6, use under adult supervision
Not recommended for use with infants

Other Information

Do not store above 105F (40.6C)

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive Ingredients

Purified water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance, Blue 1 (CI42090), Yellow 5 (CI19140)

Kit Box

Soothing Gel

Soothing Aloe

INGREDIENTS AND APPEARANCE

PURELOGIC HAND SANITIZER SOOTHING GEL AND SOOTHING ALOE 6 PACK 
alcohol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77731-045

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77731-045-01	1 in 1 BOX; Type 1: Convenience Kit of Co-Package	07/31/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	13 BOTTLE	768 mL
Part 2	13 BOTTLE	768 mL

Part 1 of 2

PURELOGIC HAND SANITIZER SOOTHING GEL 
alcohol gel

Product Information
Item Code (Source)	NDC: 77731-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77731-043-01	60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 77731-043-02	2 in 1 PACKAGE
2		354 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	07/31/2020

Part 2 of 2

PURELOGIC HAND SANITIZER SOOTHING ALOE 
alcohol solution

Product Information
Item Code (Source)	NDC: 77731-044
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77731-044-01	60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2	NDC: 77731-044-02	2 in 1 PACKAGE
2		354 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	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/31/2020

Labeler - Argento sc by sicura inc. (168718778)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Roni Cosmetic Co., Ltd		411892769	manufacture(77731-045, 77731-043, 77731-044)