FDA.reportPublic FDA data

Dermahaus

Manufacturer
Laboratorio Salutec, S.A. de C.V.
Effective date
2020-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:31:11

Label at a glance#

ProductDermahaus
Active ingredientCAMPHOR (SYNTHETIC)
Label structure12 sections

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Coconut Oil

Camphor

OTC - PURPOSE SECTION

Purpose: Pediculicide, Lice treatment

INDICATIONS & USAGE SECTION

Lice treatment shampoo kills lice and eliminates nits. Used to prevent and treat head lice infections and their eggs.

WARNINGS SECTION

For external use only.Keep out of reach of children.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears and mouth. In case of contact with eyes rinse thoroughly with water.
If swallowed, get medical help or contact poison control center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs.

OTC - DO NOT USE SECTION

On open skin wounds.
In children less than 2 months of age.

Do not wash your head with cosmetic shampoo for 24 hours after applying this product, to mantein residual efficacy.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

DOSAGE & ADMINISTRATION SECTION

Treatment- Moisten hair 1 time with this shampoo and repeat 1 week later, to ensure the total removal of lice or nits.
Prevention - Wash hair once a week with this shampoo, avoid new infestations.
How to apply - Moisten the hair and apply a sufficient amount of shampoo on the hair and scalp. Leave in contact for 10 minutes, detangle the hair with a special comb and rinse with warm water. Dry the hair and remove the parasites and nits with the fine comb. Do not wash your head with cosmetic shampoo for 24 hours after applying this product, to mantein residual efficacy. As prevention, repeat the treatment after 7 days.

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

PEG-150 Distearate
Sodium Cocoyl Isethionate
Triethanoolamine Lauryl Sulfate
Tromlamine
Coco-Betaine
Hydroxypropyl Cellulose (TypeM)
Methylchloroisothiazolinone
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront LabelBack LabelBack Label125 mL NDC: 79289-005-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79289-005-012022-01-28C16284748780-1d6a99b39-95a2-a426-e053-dadaa90af4c2af992e1b-e5b2-a8f1-e053-2995a90af96b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79289-005-01Dermahaus125 mL in 1 BOTTLESHAMPOO1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79289-005DERMAHAUS (LICE TREATMENT SHAMPOO) SHAMPOO [LABORATORIO SALUTEC, S.A. DE C.V.]1Legacy NDC, 1 package rows20201008_af992e1b-e5b2-a8f1-e053-2995a90af96b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79289-00579289-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
COCO-BETAINE03DH2IZ3FYIACT
HYDROXYPROPYL CELLULOSE (TYPE M)U3JF91U133IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af992e1b-e5b3-a8f1-e053-2995a90af96baf992e1b-e5b2-a8f1-e053-2995a90af96b2020-09-18WarningsExact identifier
spl id: af992e1b-e5b3-a8f1-e053-2995a90af96b
spl set id: af992e1b-e5b2-a8f1-e053-2995a90af96b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.