NDC | 67868-054-39 |
Set ID | 66bb7522-e702-4f74-8b7a-9ac2e1e3650f |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharma Pac, LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART333A |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
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 burnsDirections
- 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FREDS ANTISEPTIC WASH
benzalkonium chloride and lidocaine hydrochloride liquidProduct 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