OTC Medication Information: PureLogic Hand Sanitizer Soothing Gel and Soothing Aloe 6 Pack

PURELOGIC HAND SANITIZER SOOTHING GEL AND SOOTHING ALOE 6 PACK- alcohol
Argento sc by sicura 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.

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

Ethyl Alcohol 63%

Purpose:

Antimicrobial

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

image description
(click image for full-size original)

Soothing Gel

image description
(click image for full-size original)

Soothing Aloe

image description
(click image for full-size original)

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 Multilevel Packaging
1 NDC:77731-045-01 1 KIT in 1 BOX None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 63 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
CARBOMER 940
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77731-043-01 60 mL in 1 BOTTLE None
2 NDC:77731-043-02 2 BOTTLE in 1 PACKAGE contains a BOTTLE
2 354 mL in 1 BOTTLE This package is contained within the PACKAGE (77731-043-02)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 63 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALOE VERA LEAF
CARBOMER 940
TROLAMINE
.ALPHA.-TOCOPHEROL ACETATE
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77731-044-01 60 mL in 1 BOTTLE None
2 NDC:77731-044-02 2 BOTTLE in 1 PACKAGE contains a BOTTLE
2 354 mL in 1 BOTTLE This package is contained within the PACKAGE (77731-044-02)
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 Operations
Ningbo Roni Cosmetic Co., Ltd 411892769 manufacture (77731-045), manufacture (77731-043), manufacture (77731-044)

Revised: 08/2020 Argento sc by sicura inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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