TYRA TECH NATURALS LICE TREATMENT (SODIUM CHLORIDE) AEROSOL, FOAM [TYRA TECH, INC.]

TYRA TECH NATURALS LICE TREATMENT (SODIUM CHLORIDE) AEROSOL, FOAM [TYRA TECH, INC.]
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NDC 58962-001-01
Set ID d23f699e-b05b-421a-bba9-6dc3f89df5cc
Category HUMAN OTC DRUG LABEL
Packager Tyra Tech, Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Natrum Muriaticum 2X (HPUS)

  • Purpose

    Homeopathic pediculicide

  • Uses

    Treats head, pubic (crab) and body lice

  • Warnings

    For external use only

    Do not use

    • near eyes
    • inside nose, mouth or vagina
    • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

    When using this product

    • Avoid spraying in eyes
    • keep eyes tightly closed and protect eyes with a washcloth or towel
    • if product gets in eyes, flush with water right away
    • scalp itching or redness may occur.

    Stop use and ask your doctor

    • if eye irritation occurs
    • skin or scalp irritation continues or infection occurs.

    Children under 6 months: ask a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Important: Read Warnings before use
    • Adults and Children 6 months and over:
      • Shake can well before using.
      • Apply thoroughly to dry hair.
      • Saturate all hair and scalp, all lice and nits must come in contact with the product.
      • Allow product to remain on hair for 15 minutes.
      • For body and crab lice, spray on affected areas and let dry.

    To remove dead lice and their eggs (nits):

    • Use a special lice/nit comb, combing hair from as close to scalp as possible to the end of hair.
    • If hair dries during combing, apply more product.
    • After combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
    • Rinse and towel dry hair.

    Product may be used as often as needed.

  • Warning

    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not use near open flame or heated surface.

  • Other Information

    Keep out of reach of children. Store between 59-86°F (15-30°C) Do not allow container to exceed 130° F (55°C) See package insert for additional information.

  • Inactive Ingredients

    Benzyl alcohol, Butyl lactate, Cocamidopropyl Betaine, Fragrance, Germaben, Isopropyl myristate, Isopropyl alcohol, Propellant A-46, Triethyl citrate, Purified Water

  • Questions?

    1.866.951.2847 (BUGS)

    www.TyraTech.com

  • Other Information

    Head Lice

    • lay small white eggs (nits) on hair shaft close to scalp
    • nits are most easily found on back of neck or behind ears
    • disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water (above 54 deg. C (130 deg. F)), then using hottest dryer cycle for at least 20 minutes
    • items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again
    • items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose
    • soak all combs and brushes in hot water (above 54 deg. C (130 deg. F)) for at least 10 minutes
    • vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people

    Pubic (crab) lice]

    • may be transmitted by sexual contact. Sexual partners should be treated simultaneously to avoid re-infestation
    • lice are very small and look like brown or grey dots on skin
    • usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface
    • may be present on the short hairs of groin, thighs, trunk, and underarms, and occasionally on the beard and mustache
    • disinfect underwear by machine washing in hot water (above 54 deg. C (130 deg. F)), then using hottest dryer cycle for at least 20 minutes

    Body Lice

    • body lice and their eggs (nits) are generally found in the seams of clothing particularly in waistline and armpit area
    • body lice feed on skin then return to clothing to lay their eggs
    • disinfect clothing by machine washing in hot water (above 54 deg. C (130 deg. F)), then using hottest dryer cycle for at least 20 minutes [bullet] do not seal clothing in a plastic bag because nits can remain dormant for up to 30 days
  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Carton

    TyraTech
    NATURALS

    NDC: 58962-001-01

    15 minutes
    KILLS
    LICE &
    NITS

    lice treatment

    Comb Included

    • Clinically-proven
    • 100% effective against lice and nits
    • Contents can be used for up to 4 treatments
    • Easy to use mousse
    • No rinsing required
    • See insert for more information

    Net Contents
    6 fl oz (177 mL)

    NON-TOXIC

    Principal Display Panel - 177 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TYRA TECH NATURALS LICE TREATMENT 
    sodium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58962-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYL LACTATE (UNII: 0UI63W814U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58962-001-011 in 1 CARTON08/16/201304/10/2020
    1177 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/16/201304/10/2020
    Labeler - Tyra Tech, Inc. (782845882)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmasol Corporation065144289manufacture(58962-001) , label(58962-001)

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