RAPID RELIEF HOT RELIEF PATCH- methyl salicylate patch

Rapid Relief Hot Relief Patch by

Drug Labeling and Warnings

Rapid Relief Hot Relief Patch by is a Otc medication manufactured, distributed, or labeled by RAPID AID VIET NAM CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RAPID RELIEF HOT RELIEF PATCH 
methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83569-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83569-003-01	1 in 1 BOX	03/06/2024
1		6 in 1 POUCH
1		10 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	03/06/2024

Labeler - RAPID AID VIET NAM CO., LTD (673067008)

Registrant - RAPID AID VIET NAM CO., LTD (673067008)

Establishment
Name	Address	ID/FEI	Business Operations
RAPID AID VIET NAM CO., LTD		673067008	manufacture(83569-003)