RAPID RELIEF MENTHOL PAIN PATCH- menthol patch

Rapid Relief Menthol Pain Patch by

Drug Labeling and Warnings

Rapid Relief Menthol Pain 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)

Menthol 5% w/w.

Purpose

Topical analgesic

Use

Temporary relief of minor pain.

Warnings

For external use only.

Do not use

On wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

When using this product:

Use only as directed
Rear cases of serious burns have been reported with products of this type
Do not bandage tightly or use with a heating pad
Avoid contact with eyes and mucous membranes
Do not apply to wounds or damaged skin.

Do not use at the same time as other topical analgesics.

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
You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

For use by adults and children 12 years of age and older:

Carefully remove backing from patch
Apply sticky side of patch to affected area.
Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily.
Discard patch after single use.
Reseal pouch after opening.

Children under 12 years of age: consult a physician.

STORAGE AND HANDLING

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

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 MENTHOL PAIN PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83569-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TARTARIC ACID (UNII: W4888I119H)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83569-006-01	1 in 1 BOX	04/21/2024
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	04/21/2024

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(83569-006)