Label: RID LICE ELIMINATION ESSENTIALS- piperonyl butoxide, pyrethrum extract 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 November 4, 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.

  • Directions

    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 SAFETY 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

  • SPL UNCLASSIFIED SECTION

    RID Lice & Egg Comb Out Spray

  • Use

    Use

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

  • WARNINGS

    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.

  • Directions

    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 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.

  • Ingredients

    Ingredients

    Water, Glycerin, Propylene Glycol, Polysorbate 20, Cetrimonium Chloride, Amodimethicone, Phenoxyethanol, Fragrance, DL Panthenol, Trideceth-12, Methylchloroisothiazolinone, Methylisothiazolinone.

  • QUESTIONS

    Questions?

    1-800-RID-LICE (1-800-743-5423) (Mon – Fri 9AM – 8PM EST)

  • PRINCIPAL DISPLAY PANEL

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

  • PRINCIPAL DISPLAY PANEL

    Carton labelConsumer Insert - EnglishConsumer Insert - Spanish

  • INGREDIENTS AND APPEARANCE
    RID LICE ELIMINATION ESSENTIALS 
    piperonyl butoxide, pyrethrum extract kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-9070
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-9070-011 in 1 CARTON; Type 0: Not a Combination Product09/28/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 118 mL
    Part 21 BOTTLE, SPRAY 59 mL
    Part 1 of 2
    RID LICE KILLING 
    iperonyl 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
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    WATER (UNII: 059QF0KO0R)  
    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 finalpart358G09/28/2016
    Part 2 of 2
    RID LICE AND EGG COMB OUT 
    tonics, dressings, and other hair grooming aids spray
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGRDISODIUM SEC-TRIDECETH-12 SULFOSUCCINATE (UNII: 3C19U43ACC)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRCETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    INGRAMODIMETHICONE (1300 CST) (UNII: 3V7U636DWN)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic09/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358G09/28/2016
    Labeler - Bayer HealthCare LLC. (112117283)