RAPID RELIEF HOT RELIEF PATCH- methyl salicylate patch 
RAPID AID VIET NAM CO., LTD

----------

Active Ingredient(s)

Methyl Salicylate 10% w/w.

Purpose

Topical analgesic

Use

For the temporary relief of minor aches and pains of muscles and joints associated with backache, lumbago, strains, buries, sprains and arthritis or rheumatic pain, or pain of tendons and ligaments.

Warnings

For external use only.
Do not apply to sensitive skin or open wounds.
Avoid contact with eyes or mucous membranes
If excessive redness, burning or discomfort of the skin develop, discontinue use and consult a healthcare practitioner.
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 healthcare practitioner.
Never use this product with any other heating or cooling device or with other external analgesic products.
The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn.
Do not bandage this product or cover with anything other than light clothing
Do not use this product if you are allergic to salicylates or if you are taking anticoagulant medications.

Do not use

on wounds, cuts, damaged or infected skin
On eyes, mouth, genitals, or any other mucous membranes

When using this product:

You may experience a burning sensation. The intensity of this reaction varies among individuals and may be sever. With regular use, this sensation generally disappears after several days.
Avoid contact with the eyes, lips, nose and mucous membranes
Do not tightly wrap or bandage the treated area
Do not apply heat to the treated area immediately before or after use

Stop use and ask a doctor if:

Allergic reaction occurs
Condition worsens or does not improve within 7 days
Symptoms clear up and return within a few days
Redness, irritation, swelling, pain or other symptoms begin or increase

KEEP OUT OF REACH OF CHILDREN

Children 12 years of age and under: should only use this product upon the advice of a healthcare practitioner.

Directions

For use by adults and children 12 years of age and older:
Open resealable pouch and remove patch
If desired, cut patch to size
Peel off protective film and apply sticky side to desired area
Apply patch to affected area not more than 3 to 4 times daily and for no longer than 1-2 hours per application
Remove patch before applying a new one
Dispose of patch in waste receptacle after use

STORAGE AND HANDLING

Store between 15-30℃(59-86℉) keep away from children

Inactive ingredients

castor oil, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerine, menthol. Polyacrylic acid, polysorbate 80, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, water

Package Label - Principal Display Panel

image description

RAPID RELIEF HOT RELIEF PATCH 
methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83569-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
menthol (UNII: L7T10EIP3A)  
castor oil (UNII: D5340Y2I9G)  
gelatin (UNII: 2G86QN327L)  
tartaric acid (UNII: W4888I119H)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
glycerin (UNII: PDC6A3C0OX)  
water (UNII: 059QF0KO0R)  
edetate disodium (UNII: 7FLD91C86K)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83569-003-011 in 1 BOX03/06/2024
16 in 1 POUCH
110 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/06/2024
Labeler - RAPID AID VIET NAM CO., LTD (673067008)
Registrant - RAPID AID VIET NAM CO., LTD (673067008)
Establishment
NameAddressID/FEIBusiness Operations
RAPID AID VIET NAM CO., LTD673067008manufacture(83569-003)

Revised: 3/2024
Document Id: 88bbc32a-283e-42d5-8eb2-e99fc53ddc38
Set id: eaa3389c-a49c-4b4b-94f7-3b41fe9cae79
Version: 1
Effective Time: 20240306
 
RAPID AID VIET NAM CO., LTD