FREDS ANTISEPTIC WASH- benzalkonium chloride and lidocaine hydrochloride liquid

Freds Antiseptic Wash by

Drug Labeling and Warnings

Freds Antiseptic Wash by is a Otc medication manufactured, distributed, or labeled by Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                    Purpose
Benzalkonium chloride 0.13%..............................First Aid Antiseptic
Lidocaine hydrochloride 2%.................................External Antiseptic

PURPOSE

Uses- to help reduce the risk of infection in minor cuts scrapes and burns
- for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center immediately

INDICATIONS & USAGE

Uses

- to help reduce the risk of infection in minor cuts scrapes and burns
- for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

Directions

- adults and children 2 years and older:

- use to clean minor cut, scrapes and burns by thoroughly flushing the affected area
- let air dry
- cover with adhesive bandage or sterile gauze
- apply a small amount of this product on the area 1 to 3 times daily

- children under 2 years: Do not use, consult a doctor

WARNINGS

Warnings For external use only.

Do not use
- in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have - deep or puncture wounds
- animal bites - serious burns

Stop use and ask a doctor if - condition worsens - symptoms
persist for more than 7 days, or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

- adults and children 2 years and older:

- use to clean minor cut, scrapes and burns by thoroughly flushing the affected area
- let air dry
- cover with adhesive bandage or sterile gauze
- apply a small amount of this product on the area 1 to 3 times daily

- children under 2 years: Do not use, consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients aloe barbadensis gel, poloxamer 188, sodium chloride, sodium citrate, disodium EDTA, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FREDS ANTISEPTIC WASH 
benzalkonium chloride and lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67868-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLOXAMER 188 (UNII: LQA7B6G8JG)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67868-054-39	177 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333A	07/08/2010

Labeler - Pharma Pac, LLC (140807475)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture