CVS 3 STEP LICE SOLUTION- piperonyl butoxide, pyrethrum extract CVSDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CVS Haircare Lice Killing Shampoo Kit

Active ingredientPiperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Usestreats head, pubic (crab), and body lice

PurposeLice treatment

WarningsFor external use only

Do not usenear eyesinside nose, mouth, or vaginaon lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

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

When us ing this productkeep eyes tightly closed and protect eyes with a washcloth or towelif product gets into eyes, flush with water right awayscalp itching or redness may occur

Stop use and ask a doctor ifbreathing difficulty occurseye irritation occursskin or scalp irritation continues or infection occurs

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

DirectionsImportant: Read warnings before useAdults and children 2 years and over:

Inspect

Inspectcheck 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 earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this product

Treatapply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and toback of neck.allow product to remain for 10 minutes, but no longeruse warm water to form a lather, shampoo, then thoroughly rinsefor 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-awayglove).hair should remain slightly damp while removing nitsif hair dries during combing, dampen slightly with waterfor head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hairmay 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 combingclean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard toprevent lice from coming back.after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.check daily for any lice/nits that you misseda second treatment must be done in 7 to 10 days to kill any newly hatched liceif infestation continues, see a doctor for other treatmentsChildren under 2 years : ask a doctor

Other informationdo not freezestore at controlled room temperature 20°-25°C (68°-77°F)see package insert for additional information

Inactive ingredientsammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purifiedwater, SD-40 alcohol

Package Insert

Consumer Information - Package InsertEnglish

Spanish

Principal Display PanelCVS Health

Compare to the Active Ingredients in RID® Shampoo†

MAXIMUM STRENGTH

3-Step Lice Solution KitPROVEN EFFECTIVE TREATMENT

Works fast to kill liceHelps children return to school "lice free"

CAUTION: KEEP OUT OF REACH OF CHILDRENInstrucciones en español incluidas

SHAMPOO 4 FL OZ (118 mL)COMBING SPRAY 2 FL OZ (59mL)LICE SPRAY NET WT 5 OZ (142g)1 NIT REMOVAL COMB

CVS 3 STEP LICE SOLUTION piperonyl butoxide, pyrethrum extract kit

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 9 8 42-255

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 9 8 42-255-0 2 1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct 0 1/0 3/20 14

Quantity of PartsPart # Package Quantity Total Product QuantityPa rt 1 1 BOTTLE 118 mL

Part 1 of 1

LICE KILLING piperonyl butoxide, pyrethrum extract shampoo

Product InformationRoute of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

PIPERO NYL BUTO XIDE (UNII: LWK9 1TU9 AH) (PIPERONYL BUTOXIDE -UNII:LWK9 1TU9 AH)

PIPERONYLBUTOXIDE 40 mg in 1 mL

PYRETHRUM EXTRACT (UNII: ZUM0 6 L9 0 GV) (PYRETHRUM EXTRACT -UNII:ZUM0 6 L9 0 GV)

PYRETHRUMEXTRACT

3.3 mg in 1 mL

Inactive IngredientsIngredient Name Strength

PO LYQ UATERNIUM-10 ( 4 0 0 MPA.S AT 2 %) (UNII: HB140 1PQFS)

AMMO NIUM LAURETH-2 SULFATE (UNII: 6 9 8 O4Z48 G6 )

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

WATER (UNII: 0 59 QF0 KO0 R)

PEG-2 5 HYDRO GENATED CASTO R O IL (UNII: 0 ZNO9 PJJ9 J)

Product CharacteristicsColor yello w (c lo udy to transparent, c ream to straw) Score

Shape Siz e

CVS

Flavor Imprint Code

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part358 G 0 2/0 1/20 14

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph fina l part358 10 /28 /20 10

Labeler - CVS (062312574)

Registrant - Weeks & Leo Co., Inc. (005290028)

EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations

Weeks & Leo Co ., Inc . 0 0 529 0 0 28 manufacture(6 9 8 42-255)

Revised: 11/2020