Label: LICEFREEE- head lice treatment spray
- NDC Code(s): 51879-180-06, 51879-180-12
- Packager: Tec Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated October 2, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
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, 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
- KEEP OUT OF REACH OF CHILDREN
- Other information Store at 59 - 86ºF (15 - 30ºC)
- INACTIVE INGREDIENT
- QUESTIONS
-
DOSAGE & ADMINISTRATION
Directions
- Adults and children 6 months and older:
- shake well
- hold bottle 4 - 6" from head; spray on DRY hair and entire scalp, starting at the hairline and working inward toward 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 toothed 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 avoid 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
NDC 51879-180-06
Licefreee Spray! (R)
Instant Head Lice Treatment
Kills lice and eggs on contact
Mata piojos y liendres al contacto
Non-Toxic One Easy Step
No ex toxico Un paso facil
100% Guaranteed
Garantizado
Includes Professional Nit Comb
Incluye peine profesional para liendres
Homeopathic
Homeopatica
NET 6 FL OZ (177.4 mL)
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INGREDIENTS AND APPEARANCE
LICEFREEE
head lice treatment sprayProduct Information Product Type HUMAN OTC DRUG 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) poloxamer 188 (UNII: LQA7B6G8JG) benzyl alcohol (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51879-180-06 1 in 1 CARTON 05/01/2009 1 177.4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:51879-180-12 1 in 1 CARTON 05/11/2015 2 354.9 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 05/01/2009 Labeler - Tec Laboratories, Inc. (083647792) Establishment Name Address ID/FEI Business Operations Tec Laboratories, Inc. 083647792 manufacture(51879-180)