LICEFREEE ULTIMATE FAMILY KIT- head lice treatment kit

Licefreee Ultimate Family Kit by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Natrium muriaticum 1X

PURPOSE

Peduculosis remedy

INDICATIONS & USAGE

Uses

For the treatment of

• headlice
• public (crab) lice
• body lice

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• if swallowed, get medical help or contact a Poison Control Cener right away.

STORAGE AND HANDLING

Other information

Store at 59-86°F (15-30°C)

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, fragrance, poloxamer 188, purified water

QUESTIONS

Questions?

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

DOSAGE & ADMINISTRATION

Directions

• Adults and children 6 months and older:
  • shake well before each use
  • hold bottle 4-6 " from head; spray on DRY hair and entire scalp, starting at the hairline and working inward toward the crown
  • thoroughly saturate all hair and scalp; to be effective all lice and nits must come in full contact with the product
  • dead lice and nits may be removed with a fine tooth comb, if desired
  • for best results, allow product to air dry naturally, do not rinse out
  • product may be used as often as desired; washing hair regularly is recommended to aviod product build-up
  • for body and crab lice, spray on affected areas and let dry
  • Children under 6 months of age:
  • do not use; consult a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LICEFREEE ULTIMATE FAMILY KIT 
head lice treatment kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-300

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-300-12	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	02/09/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	354.9 mL

Part 1 of 1

LICEFREEE 
head lice treatment spray

Product Information
Item Code (Source)	NDC: 51879-180
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLOXAMER 188 (UNII: LQA7B6G8JG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		354.9 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		02/09/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/09/2022

Labeler - Tec Laboratories, Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories, Inc.		083647792	manufacture(51879-300)