RAPID RELIEF COLD RELIEF PATCH- menthol patch

Rapid Relief Cold Relief Patch by

Drug Labeling and Warnings

Rapid Relief Cold 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)

Menthol 4.26% 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

Glycerin, Polyacrylic acid, Polysorbate 80, Polyvinyl alcohol, Propylene glycol, Dihydroxyaluminum aminoacetate, DMDM hydantoin, Isopropyl myristate, Edetic acid, Sodium polyacrylate, Tartaric acid, Titanium dioxide, Water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

RAPID RELIEF COLD RELIEF PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83569-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	4.26 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
Propylene glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
DMDM hydantoin (UNII: BYR0546TOW)
Edetic acid (UNII: 9G34HU7RV0)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
Dihydroxyaluminum aminoacetate (UNII: DO250MG0W6)
Isopropyl myristate (UNII: 0RE8K4LNJS)
Tartaric acid (UNII: W4888I119H)
Titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83569-001-01	1 in 1 BOX	03/06/2024
1		6 in 1 POUCH
1		4.62 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(83569-001)