Active Ingredients And Purpose
OTC - PURPOSE SECTION
Topical anesthetic.
41d507c4-ad37-2686-e063-6394a90aae5b
- Set ID
- 41d507c4-ad37-2686-e063-6394a90aae5b
- Manufacturer
- Bullet point LLC | ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.
- Effective date
- 2025-10-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:41:47
Key Label Information
Uses
INDICATIONS & USAGE SECTION
For temporary relief of pain.
Warnings
WARNINGS SECTION
For external use only
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Adults and children 12 years old and over: Clean and dry the affected area. Apply 1 patch to the affected area. Do not exceed 1 patch at a time. Leave in place for up to 8 hours. Do not use more than 1 patch in 24 hours unless directed by a doctor. Children under 12 years old: ask a doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
Products
- Pain Relieveing Gel-Patch
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS | 1K713C615K | IACT |
| TARTARIC ACID | W4888I119H | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| SODIUM POLYACRYLATE (2500000 MW) | 05I15JNI2J | IACT |
| POVIDONE K90 | RDH86HJV5Z | IACT |
| POLYACRYLIC ACID (250000 MW) | 9G2MAD7J6W | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
Complete SPL Sections
DOSAGE & ADMINISTRATION SECTION
Adults and children 12 years old and over: Clean and dry the affected area. Apply 1 patch to the affected area. Do not exceed 1 patch at a time. Leave in place for up to 8 hours. Do not use more than 1 patch in 24 hours unless directed by a doctor. Children under 12 years old: ask a doctor.
WARNINGS SECTION
For external use only
INACTIVE INGREDIENT SECTION
Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water
INDICATIONS & USAGE SECTION
For temporary relief of pain.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact Poison Control.
OTC - PURPOSE SECTION
Topical anesthetic.
Source Document
Official SPL XML cached by FDA.report ยท DailyMed PDF
- XML object
- dailymed/41d507c4-ad37-2686-e063-6394a90aae5b/41d507c4-ad38-2686-e063-6394a90aae5b.xml
- XML SHA-256
- c0755d36cf82561c816c9589a7c22936a15d72baf8f4414c6f4247e451e646b7
- XML bytes
- 18303
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 41d507c4-ad38-2686-e063-6394a90aae5b.xml | 2025-11-04 |
| otc | Principal Display Panel.jpg | 2025-11-04 |