Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on skin.
Recommended for repeated use.

Warnings

For external use only.

Do not use if

you are allergic to any of these ingredients.

When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor

if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of the reach children.

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

Directions

adults and children 2 years and over:

apply to hands; allow to dry without wiping.

children under 2 years: ask a doctor before use.

To dispense: Peel back front label slowly. Remove wipes.
To reseal: Firmly rub thumb over label.

Dispose of wipe in trash. Do not flush.

For single wipe sachet

Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe.
Rub hands together briskly to dry without wiping.
Dispose of wipe
Do not flush

Other Information

Store below 95 F (35 C)
Keep closed tightly.
May discolor certain fabrics or surfaces.

For single sachet

store in a cool dry place

Inactive ingredients

Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance

Principal Display Panel

NDC 53118-002-01

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

Label

NDC 53118-002-02

Sanitex ®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

20 wipes| 6 inch x 7 inch (15.2 cm x 17.8 cm)

Label 1

NDC 53118-002-03

Sanitex ®

Antibacterial

HAND WIPE

Kills 99.9% of Germs

Enriched with Aloe

FRESH SCENT

1 Wipe | 6 inch X 8 inch (15.2 cm X 20.3 cm)

Label 2

SANITEX ANTIBACTERIAL HAND WIPES FRESH SCENT
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53118-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53118-002-01	40 in 1 CANISTER	06/17/2015
1		3 g in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:53118-002-02	20 in 1 BAG	06/17/2015
2		3 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC:53118-002-03	1 in 1 PACKAGE	07/10/2020
3		3 g in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/17/2015

Labeler - Precare Corp (858442403)

Registrant - Precare Corp (117111327)

Name	Address	ID/FEI	Business Operations
Establishment
Precare Corp		117111327	manufacture(53118-002)

Drug Facts

Active Ingredient

Purpose

Uses

Warnings

Do not use if

When using this product

Stop use and ask a doctor

Keep out of the reach children.

Directions

Other Information

Inactive ingredients

Principal Display Panel