US Favorite Hot Pain Relieving

Dosage form: liquid
Ingredients: METHYL SALICYLATE 10g in 100g
Labeler: Ken Mable
NDC Code: 42403-020

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.

US Favorite Hot Pain Relieving Patch

US Favorite Hot Pain Relieving Patch Helps Rapid Relief For Stiff Necks Shoulders, Muscle Aches and Back Pains


Drug Facts


Active Ingredient

Methyl Salicylate 10% (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only


When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damages skin, broken or irritated skin

Stop use and ask a doctor if
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health 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:

  • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • apply one patch to affected area
  • wear one Icy Hot Patch up to 8 hours
  • repeat as necessary, but no more than 3 times daily
children 12 years or younger: ask a doctor

Inactive ingredients

alicylic saturated hydrocarbon resin, backing cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-styrene block copolymer, synthetic aluminum silicate

Distributed By: Ken Mable INC. 156 Flushing Ave Brooklyn, NY 11205 Made in P.R.C. www.kmbusa.com


US Favorite Hot Pain Relieving Patch (5 Patches)
US Favorite Hot
Hydrogel Patch
Pain Relieving Patch

Helps Rapid Relief For Stiff Necks
Shoulders, Muscle Aches and Back Pains

  • Soothes pain Naturally
  • Reusable patch
  • Non greasy Formula
  • Soft, flexible
  • Removes easy
5 Pads (8 x 12cm)



US FAVORITE HOT PAIN RELIEVING 
methyl salicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42403-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
POLYISOBUTYLENE (1100000 MW) 
STYRENE 
ISOPRENE 
ALUMINUM SILICATE 
Packaging
#Item CodePackage Description
1NDC:42403-020-055 PATCH (PATCH) in 1 POUCH
114 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/04/2012
Labeler - Ken Mable (040265356)
Registrant - Shanghai Aquagel Bio-polymer Co., Ltd. (421199544)
Establishment
NameAddressID/FEIOperations
Shanghai Aquagel Bio-polymer Co., Ltd.421199544manufacture

Revised: 02/2012
 
Ken Mable

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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