Label: LICEFREEE- sodium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51879-121-08, 51879-121-80 - 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 22, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
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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
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LICEFREEE
sodium chloride gelProduct 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)
