DR. SCHOLLS BLISTER PAIN RELIEF COMPLETE- lidocaine kit

Dr. Scholls Blister Pain Relief Complete by

Drug Labeling and Warnings

Dr. Scholls Blister Pain Relief Complete by is a Otc medication manufactured, distributed, or labeled by Scholl's Wellness Company LLC, Shanghai Sibei Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

External Analgesic

Use

Temporarily relieves pain

Warnings

For external use only

• Avoid contact with eyes
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do not use

• More than one patch on your body at a time
• If you have had an allergic reaction to lidocaine or other local anesthetics
• Do not use in large quantities, particularly over raw surfaces or blistered areas
• For more than one week without consulting a doctor.

When using this product

• Use only as directed. Read and follow all directions and warnings on this carton

Stop use and ask a doctor if

• condition worsens
• severe burning sensation, redness, rash or irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breast-feeding, 

ask a health care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

Step 1 (Lidocaine patch application)  apply to the affected area not more than 3-4 times daily

• clean and dry affected area
• remove backing from lidocaine patch by firmly grasping both ends and gently pulling away backing
• once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
• once applied, press firmly on patch to help adhesive adhere to blister
• do not remove patch and reapply
• once patch is applied, move to Step 2.

Step 2 (Bandage application) remove backing film from hydrogel bandage marked "Step 1" and place center (adhesive side down) over skin to seal lidocaine patch and blister.

• remove backing film marked "Step 2" and firmly smooth down adhesive edge to skin to seal lidocaine patch and blister. Replace when bandage begins to loosen

children 12 years or younger: ask a doctor

Other information

Store between 20-25°C (68-77°F)

Inactive ingredients

Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Silica Silylate, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tocopherol Acetate, Vanillyl Butyl Ether, Urea, Water (Aqua)

Questions?

1-866-360-3226

Package Labeling:

INGREDIENTS AND APPEARANCE

DR. SCHOLLS BLISTER PAIN RELIEF COMPLETE 
lidocaine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73469-0488

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73469-0488-2	1 in 1 KIT	02/15/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	12 PATCH	4.44 g

Part 1 of 1

DR SCHOLL S 4 LIDOCAINE EXTERNAL ANALGESIC 
lidocaine patch

Product Information
Item Code (Source)	NDC: 75568-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE GUM (UNII: K679OBS311)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75568-024-01	1 in 1 POUCH
1		0.37 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/15/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/15/2025

Labeler - Scholl's Wellness Company LLC (117174744)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Sibei Cosmetic Co., Ltd.		542969967	pack(75568-024)