LICEFREEE- sodium chloride gel

Licefreee by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Natrum muriaticum 2X HPUS(Sodium chloride)

PURPOSE

Purpose

Pediculosis remedy

INDICATIONS & USAGE

Uses

• For the treatment of
• head lice
• pubic (crab) lice
• body lice

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have

infestation of eyebrows or eyelashes

WHEN USING

When using this product

• do not use in or near the eyes
• do not permit contact with mucous membranes, such as inside the nose, mouth,or vagina,as irritation or stinging may occur
• close eyes tightly while hair is being rinsed;do not open eyes until product is rinsed out
• tingling may occur during the first 10 minutes of application; this is normal and should go awa'f, if it doesn't, rinse hair immediately and discontinue use

STOP USE

Stop use and ask a doctor if

skin irritation or infection is present or develops

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.

DOSAGE & ADMINISTRATION

Directions

adults and children 6 months of age and older.

shake well

remove cap and tamper evident seal; replace with enclosed root applicator

apply to DRY hair and entire scalp, starting at the nape of the neck and behind ears (where lice congregate) and work forward

thoroughly saturate all hair and scalp; to be effective,all lice and nits must come in full contact with the product

put plastic cap on head and leave on for at least 60 minutes;for best results stay in a warm room

never leave a child unattended with plastic cap on

with product still in hair,remove plastic cap and comb out all dead lice and nits with enclosed fine toothed comb;rinse comb out under running water

once all lice and nits are combed out,rinse hair thoroughly with warm running water

thoroughly inspect and comb hair and scalp a second time to ensure complete removal of all lice and nits

Licefreee! may be used as often as necessary; a second treatment in 7-10 days is recommended to kill any newly hatched lice

children under 6 months of age:

do not use, consult a doctor

STORAGE AND HANDLING

Other lnfonnation

Store at 59 - 86'F (15 - 30'C)

INACTIVE INGREDIENT

Inactive Ingredients

aminomethyl propanol, anise oil, carbomer,cocamidopropyl betaine, fragrance, PEG-6 caprylic/capric glycerides, purified water

QUESTIONS

Questions?

Call 1-800-482-4464 .Serious side effects can be reported to this number.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LICEFREEE 
sodium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	2 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
ANISE OIL (UNII: 6Y89129C8H)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-121-08	1 in 1 CARTON	04/30/2016
1	NDC: 51879-121-80	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/30/2016

Labeler - Tec Laboratories, Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories, Inc.		083647792	manufacture(51879-121)