Indications and uses
For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac.
Painsil Pain Relief Roll-On
- Manufacturer
- Painsil LLC | Pure Source, LLC
- Effective date
- 2026-07-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-07-18 05:10:17
Label at a glance#
ProductPainsil Pain Relief Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Label contents#
Full prescribing information#
Active ingredients
Lidocaine hydrochloride 4.00%
Purpose
Topical Analgesic
Uses:
- For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac.
Warnings:
For external use only
Do not use
- In large quantities, particularly over raw surfaces or blistered areas.
When using this product
- Avoid contact with the eyes
Stop use and ask a doctor if
- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding,
ask a health professional before use.
Directions:
- Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: consult a doctor.
Other Information
- Store at 20–25°C (68–77°F) and protect from moisture.
Inactive Ingredients:
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Menthol, Polysorbate 60, Sorbitan Isostearate, Steareth-2, Steareth-21, Water (Aqua)
Questions?
support@painsil.com
Package Labeling:
Products#
Every source-derived product name is available through these pages.
- Painsil Pain Relief Roll-On
- LIDOCAINE HYDROCHLORIDE
- ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)
- ALCOHOL
- ALOE VERA LEAF JUICE
- AMINOMETHYLPROPANOL
- C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER
- CAPRYLYL TRISILOXANE
- CETOSTEARYL ALCOHOL
- CETETH-20 PHOSPHATE
- DIHEXADECYL PHOSPHATE
- DIMETHICONE
- EDETATE DISODIUM
- GLYCERYL MONOSTEARATE
- HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)
- ISOHEXADECANE
- MENTHOL, UNSPECIFIED FORM
- POLYSORBATE 60
- SORBITAN ISOSTEARATE
- STEARETH-2
- STEARETH-21
- WATER
- LIDOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87848-001 | 87848-001-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Painsil Pain Relief Roll-On | LIDOCAINE HYDROCHLORIDE | Painsil LLC | dee39dff-5749-4ef2-a9ed-182f25e01f67 | 2026-07-14 | Warnings | 87848-001-00 87848-001 87848000100 568f6bb5-7040-5efa-e063-6294a90a1da4 dee39dff-5749-4ef2-a9ed-182f25e01f67 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.