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NDC 75940-0171-04 Herklin 40; .033 mg/mL; mg/mL Details
Herklin 40; .033 mg/mL; mg/mL
Herklin is a TOPICAL SHAMPOO in the HUMAN OTC DRUG category. It is labeled and distributed by MarcusUSA. The primary component is PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT.
Product Information
| NDC | 75940-0171 |
|---|---|
| Product ID | 75940-171_6c7c7bed-7527-44ce-9616-f155db2e4753 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Herklin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Piperonyl butoxide and Pyrethrum extract |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SHAMPOO |
| Route | TOPICAL |
| Active Ingredient Strength | 40; .033 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | PIPERONYL BUTOXIDE; PYRETHRUM EXTRACT |
| Labeler Name | MarcusUSA |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part358G |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 75940-0171-04 (75940017104)
| NDC Package Code | 75940-171-04 |
|---|---|
| Billing NDC | 75940017104 |
| Package | 1 BOTTLE in 1 CARTON (75940-171-04) / 236 mL in 1 BOTTLE |
| Marketing Start Date | 2017-10-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 908f9a80-d1cf-448e-8e35-e4dc856e0e99 Details
SPL UNCLASSIFIED SECTION
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. May cause breathing difficulty or an asthmatic attack.
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
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
- 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
- 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
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Carton
MAXIMUM STRENGTH
• PROUDLY SERVING FAMILIES FOR •
38
YEARS
HERKLIN®
LICE TREATMENT
Piperonyl butoxide 4%
Pyrethrum extract (0.33% pyrethrins)
Kills Lice &
Eliminates Nits*
Effective & safe for ages 2+
NEED HELP? •
Toll
Free
(844) HERKLIN
(437-5546)
INCLUDES:
Shampoo, Lice
& Nit Comb
LICE COMB INCLUDED
8 fl oz (236 mL)
*Proper use of nit comb removes nits.
INGREDIENTS AND APPEARANCE
| HERKLIN
piperonyl butoxide and pyrethrum extract shampoo |
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| Labeler - MarcusUSA (016139820) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Weeks & Leo Co.Inc | 005290028 | MANUFACTURE(75940-171) | |
Revised: 11/2017
Document Id: 6c7c7bed-7527-44ce-9616-f155db2e4753
Set id: 908f9a80-d1cf-448e-8e35-e4dc856e0e99
Version: 1
Effective Time: 20171107