Label: LICEOUT- piperonyl butoxide and pyrethrum extract shampoo
- NDC Code(s): 53247-124-01, 53247-124-02
- Packager: Bob Barker Company Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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.
Ask a doctor before use if you are
- allergic to ragweed.
- if product gets in eyes, flush with water right away
- scalp itch-ing or redness may occur.
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Directions
Shake Well Before Using
Adults and children 2 years and over.
Treat
- Apply thoroughly to 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.
- Check daily for any lice/nits.
- 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.
- Other Information
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 Sachet Case
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INGREDIENTS AND APPEARANCE
LICEOUT
piperonyl butoxide and pyrethrum extract shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53247-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Piperonyl butoxide (UNII: LWK91TU9AH) (Piperonyl butoxide - UNII:LWK91TU9AH) Piperonyl butoxide 3 g in 100 mL Pyrethrum Extract (UNII: ZUM06L90GV) (Pyrethrum Extract - UNII:ZUM06L90GV) Pyrethrum Extract 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength C13-14 ISOPARAFFIN (UNII: E4F12ROE70) OCTOXYNOL-9 (UNII: 7JPC6Y25QS) water (UNII: 059QF0KO0R) Benzyl Alcohol (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53247-124-01 150 in 1 CASE 01/02/2022 1 29.6 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:53247-124-02 3785 mL in 1 JUG; Type 0: Not a Combination Product 01/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M031 01/02/2022 Labeler - Bob Barker Company Inc. (058525536)