Otc - Active Ingredient
| Active Ingredients | Purpose |
| Menthol 0.5% | Topical Analgesic |
Lansinoh Anti-itch
FDA Label NDC 53997-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lansinoh Laboratories Inc for the product Lansinoh Anti-itch (NDC 53997-002). 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 - ask doctor, otc - do not use, otc - keep out of reach of children, otc - purpose, otc - stop use, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Stop Use and ask a doctor
- if condition worsens
- if symptoms persist for more than 7 days
- Or if symptoms clear up and occur again withina few days
Otc - Do Not Use
Do NOT use in or near mouth, or on breasts or nipples when breast feeding.
Pregnant women are advised to consult their physician before using any OTC drug product.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
if swallowed, get medical help or contact a Poison Control Center right awau (1-800-222-1222)
Otc - Purpose
For temporary relief of itching
Otc - Stop Use
Stop use and ask a doctor
- If condition worsens
- If symptoms persists for more than 7 days
- Or if symptoms clear up and occur again within a few days
Warnings
Warnings
For external use only
Avoid contact withthe eyes
Dosage & Administration
Directions
- For adults and children 2 years and older
- Apply externally to the affected area, no more than 3-4 times daily
Inactive Ingredient
Inactive Ingredients:
Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Meal Extract, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cucumis Sativus Fruit Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Hyaluronic Acid, Hydrolyzed Jojoba Esters, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Palmitate, Polysorbate 60, Prunus Armeniaca (Apricot) Kernel Oil), Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Potassium Sorbate, Sodium Chloride, Sodium Hydroxide, Sorbitan Isostearate, 1,2-Hexanediol, Sorbitan Olivate, Squalane, Water (Eau, Aqua).
Indications & Usage
Uses
For temporary relief of itching
Package Label.Principal Display Panel
Front (Front)
Display Cartoon (Dc1)
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