Otc - Active Ingredient
Coconut Oil
Camphor
Dermahaus
FDA Label NDC 79289-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Salutec, S.a. De C.v. for the product Dermahaus (NDC 79289-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Pediculicide, Lice treatment
Indications & Usage
Lice treatment shampoo kills lice and eliminates nits. Used to prevent and treat head lice infections and their eggs.
Warnings
For external use only.Keep out of reach of children.
Otc - When Using
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
Stop use and ask a doctor if irritation or rash occurs.
Otc - Do Not Use
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
Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.
Dosage & Administration
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
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
PEG-150 Distearate
Sodium Cocoyl Isethionate
Triethanoolamine Lauryl Sulfate
Tromlamine
Coco-Betaine
Hydroxypropyl Cellulose (TypeM)
Methylchloroisothiazolinone
Water
Package Label.Principal Display Panel
Front Label (Dh Lf1)
Back Label (Dh Lb1)
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