Drug Facts
| Active Ingredient | Purpose |
| Lidocaine 4% | Topical Analgesic |
Lansinoh Pain Relieving Spray
FDA Label NDC 53997-001
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 Pain Relieving (NDC 53997-001). 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 drug facts, stop use and ask a doctor, keep out of reach of children, warnings, otc - stop use, dosage & administration, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Stop Use And Ask A Doctor
Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few day
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.
Warnings
Warnings
For external use only.
Do NOT use on breasts, nipples, in or
near mouth.
KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.
If swallowed, get medical help or contact
a Poison Control Center right away.
FOR EXTERNAL USE ONLY
Otc - Stop Use
Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few days
Dosage & Administration
Directions ■ For adult use only
■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.
Inactive Ingredient
Inactive Ingredients:
Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.
Distributed By: Lansinoh Laboratories, Inc
Alexandria, VA 22314, USA
Tel: +1-800-292-4794 | www.lansinoh.com
Indications & Usage
For external use only
Otc - Purpose
Topical Analgesic
* Please review the disclaimer below.
