LICEFREEE AFTERLICE- pramoxine hci spray

Licefreee AfterLice by

Drug Labeling and Warnings

Licefreee AfterLice by is a Otc medication manufactured, distributed, or labeled by Tec Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Pramoxine HCI 1%

WARNINGS

For external use only

WHEN USING

When using this product

• avoid contact with eyes

STOP USE

Stop use and ask a doctor if

• condition worstens
• symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

STORAGE AND HANDLING

Other Information

Store at 59-86ºF (15-30ºC)

INACTIVE INGREDIENT

Inactive ingredients

alcohol, benzethonium CI, menthol, panthenol, polyoxyl 35 castor oil, polyquaternium-10, purified water, tea tree oil

QUESTIONS

Questions or comments?

Call 1-800-482-4464.

INDICATIONS & USAGE

Uses

for the temporary relief of itching associated with

• insect bites
• minor skin irritations

DOSAGE & ADMINISTRATION

Directions

• Adults and children 2 years of age and older: spray on affected area not more than 3-4 times daily
• Children under 2 years; do not use; consult a doctor

PURPOSE

Pain and itch relief spray for scalp irritation caused by lice bites and lice treatments.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LICEFREEE AFTERLICE 
pramoxine hci spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
MENTHOL (UNII: L7T10EIP3A)
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-260-06	177.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/16/2023

Labeler - Tec Laboratories Inc. (083647792)

Registrant - Tec Laboratories Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories Inc.		083647792	manufacture(51879-260)