Rapid Relief Hot Relief Patch by RAPID AID VIET NAM CO., LTD

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]

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

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Active Ingredient(s)

Capsaicin 0.013 %

Purpose

Topical analgesic

Use

For temporary relief of minor pain associated with:
arthritis,
simple backache,
strains,
sprains,
bruises

Warnings

For external use only.

Do not use

 On wounds or damaged skin
With a heating pad

When using this product:

 Use only as directed
 Do not bandage tightly
 Avoid contact with eyes, mucous membranes or rashes
 Discontinue use at least 1 hour before a bath or shower
 Do not use immediately after a bath or shower

Stop use and ask a doctor if:

 Condition worsens, Symptoms persist for more than 7 days or clear up and occur again within a few days.
 Redness is present or irritation or rash develops.
 A sever burning sensation occurs.

KEEP OUT OF REACH OF CHILDREN

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

If pregnant or breast feeding

ask a health professional before use.

Directions

Adults and children 12 years of age and older:
 Clean and dry affected area
 Remove film from patch and apply to the skin
 Apply 1 patch at a time to the affected area, not more than 3 to 4 times daily.
 Remove patch from the skin after at most 8-hour application.
Children under 12 years of age: consult a doctor

STORAGE AND HANDLING

 Avoid storing product in direct sunlight
 Protect product from excessive moisture

Inactive ingredients

Acyclovir, Dihydroxyaluminum aminoacetetel, DMDM hydantoin, Edetate Disodium Anhydrous, Glycerin, Polyacrylic acid, Sodium polyacrylate, Sodium Acryloyldimethyltaurate-acrylamide copolymer, Tartaric acid, Titanium dioxide, Water

RAPID RELIEF HOT RELIEF PATCH 
methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83569-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.013 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ACYCLOVIR (UNII: X4HES1O11F)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83569-004-01	1 in 1 BOX	03/25/2024
1		6 in 1 POUCH
1		0.013 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	03/25/2024	04/01/2024

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(83569-004)

Revised: 3/2024

Document Id: 1500b291-0acb-0b03-e063-6294a90ab4c3

34390-5

Set id: a0dfb51b-3993-4480-bd81-8ae2b0ffc4b5

Version: 2

Effective Time: 20240331