RAPID RELIEF HOT RELIEF PATCH- capsaicin 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)

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RAPID RELIEF HOT RELIEF PATCH 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83569-005
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: 83569-005-01	1 in 1 BOX	03/31/2024
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	03/31/2024

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(83569-005)