LICEFREEE- sodium chloride kit

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]

Licefreee Shampoo Everyday!

Active Ingredient

Natrum muriaticum 2X HPUS (Sodium chloride)

PURPOSE

Purpose

Pediculosis remedy

INDICATIONS & USAGE

Uses

• Use daily to help avoid head lice reinfestation.

WARNINGS

Warnings

For external use only.

ASK DOCTOR

Ask a doctor before use if you

• have infestation of eyebrows or eyelashes
• are pregnant

WHEN USING

When using this product

• do not use in or near the eyes; close eyes while product is being applied
• do not permit contact with mucous membranes, such as inside the nose as irritation or stinging may occur

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 and older:
• for best results on a head lice infestation, use Licefreee Spray!® or Licefreee!® Gel treatment before using this shampoo.
• apply a generous amount of shampoo to wet hair, work into a lather while massaging into scalp; rinse
• repeat, this time leaving the shampoo on the hair for 2 minutes; rinse
• use daily for at least 7-10 days to treat any lice that have hatched.
• Children under 6 months:
• do not use; consult a doctor

STORAGE AND HANDLING

Other information

store at 59-86°F (15-30°C)

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, cocamidopropyl betaine, disodium EDTA, fragrances, polyquaternium 10, purified water, sodium lauryl sulfate, tea tree oil

QUESTIONS

Questions?

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

Licefreee! Gel Lice Treatment

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 away; 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 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 Information​

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

NDC: 51879-122-88

Original Non-Toxic

Licefreee! Kit

Includes:

Licefreee!® Gel Head Lice Treatment

Licefreee® Everyday! Shampoo

KILLS SUPER LICE and EGGS

MATA PIOJOS Y LIENDRES

Shampoo helps Avoid Lice Reinfestation with daily use

Ayuda y evitar infestación de

piojos al usarse diariamente

Homeopathic

Homeopática

CONTENTS:

Homeopathic

Homeopática

CONTENTS:

Licefreee Gel NET WT 8 OZ (227g)

Licefreee Shampoo NET 8 FL OZ (236.6 mL)

Professional Nit Comb

Piene Profesional para Liendres

INGREDIENTS AND APPEARANCE

LICEFREEE 
sodium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-122

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-122-88	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	07/13/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE, PLASTIC	1 g
Part 2	0 BOTTLE, PLASTIC	1 mL

Part 1 of 2

LICEFREEE 
sodium chloride gel

Product Information
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
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ANISE OIL (UNII: 6Y89129C8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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		07/30/2016

Part 2 of 2

LICEFREEE EVERYDAY 
sodium chloride shampoo

Product Information
Item Code (Source)	NDC: 51879-191
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 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TEA TREE OIL (UNII: VIF565UC2G)
POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-191-08	236.6 mL 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		07/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/13/2016

Labeler - Tec Laboratories, Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories, Inc.		083647792	manufacture(51879-122)