Pain Relief Gel-Patch: Package Insert and Label Information

PAIN RELIEF GEL-PATCH- menthol and lidocaine patch
R & Y Group, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Lidocaine 4.0% w/w …… Purpose: Topical anesthetic

Menthol 1.0% w/w …… Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

For temporary relief of pain

Warnings

  • Use only as directed
  • 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 physician

When using this product

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Do not use

  • More than 1 patch at a time
  • If you are allergic to any ingredients of this product
  • On wounds or damaged skin

Stop use and consult a doctor if

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • Conditions worsen
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a physician before use

Keep out of reach of children

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

Directions

Adult and Children 12 years of age and over :

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply to affected area not more than 3 to 4 times daily
  • Remove patch from the skin after 8-hour application, at most

Children under 12 years of age : Consult a physician

Inactive Ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Polysorbate 80, Mineral Oil, Polyvinylpyrrolidone K90, Hydroxyacetophenone, L(+)-Tartaric Acid, Dihydroxyaluminium Aminoacetate, Edetate Disodium, Kaolin, Titanium Dioxide

Other information

  • Store at 68° — 77° F (20° — 25° C)
  • Store in a cool dry place away from direct sunlight

Package label. Principal display panel

83016-172-01A
(click image for full-size original)
83016-172-01B
(click image for full-size original)
83016-172-07
(click image for full-size original)

PAIN RELIEF GEL-PATCH
lidocaine, menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:83016-172
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.03 g in 3 g
LIDOCAINE (LIDOCAINE) LIDOCAINE 0.12 g in 3 g
Inactive Ingredients
Ingredient Name Strength
KAOLIN
TARTARIC ACID
WATER
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
PROPYLENE GLYCOL
POLYACRYLIC ACID (250000 MW)
SODIUM POLYACRYLATE (2500000 MW)
TITANIUM DIOXIDE
MINERAL OIL
POLYSORBATE 80
GLYCERIN
EDETATE DISODIUM
POVIDONE K90
HYDROXYACETOPHENONE
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83016-172-07 7 PACKET in 1 POUCH contains a PACKET (83016-172-01)
1 NDC:83016-172-01 3 g in 1 PACKET This package is contained within the POUCH (83016-172-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/26/2022
Labeler — R & Y Group, LLC (968585765)
Registrant — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Establishment
Name Address ID/FEI Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture (83016-172)

Revised: 10/2022 R & Y Group, LLC

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