Label: RID LICE TREATMENT COMPLETE KIT kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 12, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Shampoo

  • ACTIVE INGREDIENT

    Active ingredients

    Piperonyl butoxide (4%)

    Pyrethrum extract (equivalent to 0.33% pyrethrins)

  • PURPOSE

    Purpose

    Lice treatment

  • Uses

    Uses treats head, pubic (crab), and body lice

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    · near the eyes

    · inside the nose, mouth, or vagina

    · on lice in eyebrows or eyelashes. See a doctor if lice are present

    in these areas.

    · if you have ever had an allergic reaction to this product or any of its

    ingredients

  • ASK DOCTOR

    Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

  • WHEN USING

    When using this product

    ● 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

    Stop use and ask a doctor if

    ● breathing difficulty occurs

    ● eye irritation occurs

    ● skin or scalp irritation continues or infection occurs

  • 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

    ● Important: Read warnings before use

    Adults and children 2 years and over:

    Inspect

    ● check each household member with a magnifying glass in bright

    light for lice/nits (eggs)

    ● look for tiny nits near scalp, beginning at back of neck and

    behind ears

    ● examine small sections of hair at a time

    ● unlike dandruff which moves when touched, nits stick to the hair

    ● if either lice or nits are found, treat with this product

    Treat

    ● apply thoroughly to DRY HAIR or other affected area. For head

    lice, first apply behind ears and to back of neck.

    ● allow product to remain for 10 minutes, but no longer

    ● use warm water to form a lather, shampoo, then thoroughly

    rinse

    ● for head lice, towel dry hair and comb out tangles

    Remove lice and their eggs (nits)

    ● use a fine-tooth or special lice/nit comb. Remove any remaining

    nits by hand (using a throw-away glove).

    ● hair should remain slightly damp while removing nits

    ● if hair dries during combing, dampen slightly with water

    ● for head lice, part hair into sections. Do one section at a time

    starting on top of head. Longer hair may take 1 to 2 hours.

    ● lift a 1- to 2-inch wide strand of hair. Place comb as close to

    scalp as possible and comb with a firm, even motion away from

    scalp.

    ● pin back each strand of hair after combing

    ● clean comb often. Wipe nits away with tissue and discard in a

    plastic bag. Seal bag and discard to prevent lice from coming

    back.

    ● after combing, thoroughly recheck for lice/nits. Repeat combing

    if necessary.

    ● check daily for any lice/nits that you missed

    ● a second treatment must be done in 7 to 10 days to kill any

    newly hatched lice

    ● if infestation continues, see a doctor for other treatments

    Children under 2 years: ask a doctor

  • Other information

    Other information

    ● keep carton for important product information

    ● see Consumer Information Insert for additional information

    ● avoid excessive heat

  • INACTIVE INGREDIENT

    Inactive ingredients ammonium laureth sulfate, dehydrated alcohol, fragrance, isopropyl alcohol, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water

  • Questions or Comments

    Questions or comments? 1-800-RID-LICE (1-800-743-5423) (Mon – Fri 9AM – 8PM EST) www.ridlice.com

  • SPL UNCLASSIFIED SECTION

    Lice & Egg Comb Out Spray

  • Use

    RID® Lice & Egg Comb-Out Spray detangles hair in order to make lice and egg comb-out easier.

  • WARNINGS

    For external use only. Keep out of reach of children. Avoid contact with eyes. Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • INDICATIONS & USAGE

    Directions For Use

    Before using, read Consumer Information Insert for complete directions.

    ● Use AFTER shampooing with RID® Lice Killing Shampoo.

    ● Towel dry hair. Apply a small amount of RID® Lice & Egg Comb-Out Spray and use a wide-toothed

    comb to remove any tangles.

    ● Comb out the dead lice, eggs, and nits, one small section at a time, with the enclosed RIDvantage® Jr.

    Lice Comb. (See insert for additional combing instructions). This step is very important.

    ● Use additional RID® Lice & Egg Comb-Out Spray to remove tangles, if needed, during the comb-out

    process.

    ● After you have combed entire head, rinse hair thoroughly with warm water. Disinfect combs with hot water (130ºF).

  • OTHER SAFETY INFORMATION

    Other Information

    ● It is important to wash in hot water (130ºF) all clothing, bedding, towels, and hair products (combs,

    brushes) used by infested persons in the two days prior to treatment.

    ● Dry clean non-washable fabrics.

    ● To eliminate infestation of furniture and bedding that cannot be washed or dry cleaned, a multi-use lice

    spray such as RID® Home Lice, Bedbug & Dust Mite Spray may be used.

    RID® Lice & Egg Comb-Out Spray does not kill lice or their eggs. Use this product only after treating

    with RID® Lice Killing Shampoo.

    ● Store in a cool, dry place. Keep from freezing.

  • QUESTIONS

    Questions?

    1-800-RID-LICE (1-800-743-5423)

  • Consumer Information

    Insert EnglishInsert - Spanish

  • PRINCIPAL DISPLAY PANEL

    RID

    LICE TREAMENT

    COMPLETE KIT

    LICE TREATMENT

    Easy-to-Follow 3-step Process

    Instructions inside

    1. Treat
    2. Remove
    3. Control

    24/7

    SUPPORT

    CALL AN EXPERT

    1-800-RID-LICE

    HOW--TO VIDEOS

    TRATAMIENTO DE PIOJOS--KIT COMPLETO

    Se incluyen instrucciones en espanol

    SHAMPOO NET WT. 4 FL OZ (118 mL)

    COMB-OUT SPRAY NET WT. 2 FL OZ (59 mL)

    RID® HOME LICE, BEDBUG & DUST MITE SPRAY

    NET WT. 3 oz (851 g)

    1 PATENTED® RID LICE COMB

    KEEP OUT OF REACH OF CHILDREN

    CAUTION

    See Back Panel for Additional Precautions

    Label complete kit

  • INGREDIENTS AND APPEARANCE
    RID LICE TREATMENT COMPLETE KIT 
    rid lice treatment complete kit kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-9050
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-9050-011 in 1 CARTON; Type 0: Not a Combination Product05/09/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE 59 mL
    Part 1 of 2
    RID LICE KILLING 
    piperonyl butoxide, pyrethrum extract shampoo
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT3.3 mg  in 1 mL
    PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G05/09/2016
    Part 2 of 2
    LICE AND EGG COMB OUT 
    other hair preparations spray
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRAMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    INGRSEC-TRIDECETH-12 (UNII: 6WTE57JSWS)  
    INGRMETHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic05/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35805/09/2016
    Labeler - Bayer HealthCare LLC (112117283)