PERSONAL CARE- alcohol, benzethonium chloride kit

Personal Care by

Drug Labeling and Warnings

Personal Care by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Ningbo Unichem Household Products Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Personal Care

Antibacterial

Kills 99.9 percent of Germs

Hand Sanitizer

Kills Germs Without Water

Ideal for use in Car, School, and Office.

Travel Size Bottle

Plus 4 Free Wipes

1 Bottle: 2 FL OZ 59 ML

4 Individually Wrapped Wipes 7 inches X 5 inches   18 CM X 13 CM Each

PRINCIPAL DISPLAY PANEL

Personal Care

Hand Sanitizer

Kills Germs Without Water

Convenient Size Carry in:

Purse

Pocket

Briefcase

Backpack

Glove Box

Use Anyplace

Home

School

Work Outdoors

and More

Instant Hand Sanitizer Wipes         Instant Hand Sanitizer Gel

Distributed by:

Personal Care Products, Inc.

Bingham Farms, MI 48025-2463

Made in China

Kills 99.9 percent of many common germs.

ACTIVE INGREDIENT

Drug Facts

Active Ingredient                              Purpose

Ethyl Alcohol 62.0 percent               Antiseptic

PURPOSE

Uses hand sanitizer to help reduce bacteria on the skin.

WARNINGS

Warnings
For external use only.

SAFE HANDLING WARNING

Flammable. Keep away from heat and flame.

WHEN USING

When using this product avoid contact with face, eyes, and broken skin.
In  case of eye contact, flush with plenty of water and seek medical advice.

STOP USE

Stop use and ask  a doctor if irritation or redness develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center.

DOSAGE & ADMINISTRATION

Directions

Wet hands thoroughly with product and rub into skin until dry.

Children under 6 years of age should be supervised by an adult when using.

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, carbomer, fragrance, glycerin,

propylene glycol, tocopheryl acetate vitamin E, triethanolamine, water aqua

ACTIVE INGREDIENT

Drug Facts

Active Ingredient                                                  Purpose

Benzethonium Chloride 0.3 percent                   Antiseptic

DO NOT USE

Do not use in the eyes.

In case of contact, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.

INDICATIONS & USAGE

Directions

Tear open packet, remove and unfold wipe

Thoroughly wipe hands (palms, backs and between fingers)

Supervise children in use of this product

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA , ethyl alcohol,

fragrance, methylparaben, PEG 60 lanolin, PEG dimethicone, potassium sorbate,

propylparaben, quaternium 52, water aqua

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PERSONAL CARE 
alcohol, benzethonium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-1000

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-1000-4	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	60 mL
Part 2	4 PACKET	4

Part 1 of 2

PERSONAL CARE 
alcohol gel

Product Information
Item Code (Source)	NDC: 29500-9085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9085-1	60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Part 2 of 2

PERSONAL CARE WET WIPES 
benzethonium chloride swab

Product Information
Item Code (Source)	NDC: 29500-9084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.003 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
LANOLIN (UNII: 7EV65EAW6H)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-9084-2	1 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	11/01/2009

Labeler - Personal Care Products, Inc. (603124298)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Unichem Household Products Co., Ltd		528196956	manufacture