COLD AND HOT MEDICATED by Universal Distribution Center LLC

COLD AND HOT MEDICATED by

Drug Labeling and Warnings

COLD AND HOT MEDICATED by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLD AND HOT MEDICATED- menthol patch 
UNIVERSAL DISTRIBUTION CENTER, LLC

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5% Menthol Pain Relief Patch (2 Patches/Pouch) NDC: 52000-422-41

Uses

Topical Analgesic
Temporary relieve minor pain ssociated with:

• Arthritis
• Simple Backache
• Muscle Strains
• Bursitis
• Tendonitis
• Strains
• Bruises
• Cramps

Warnings

WARNINGS

For external use only.

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with the eyes and mucous membranes
• do not apply to wounds or damaged skin

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
• skin irritation develops.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80

Directions

Directions

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area.
• Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 times a day
• Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

Keep out of reach of children.

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

5% Menthol Pain Relief Patch (24 Pouches/Box) NDC: 52000-422-42

Uses

Topical Analgesic
Temporary relieve minor pain ssociated with:

• Arthritis
• Simple Backache
• Muscle Strains
• Bursitis
• Tendonitis
• Strains
• Bruises
• Cramps

Warnings

WARNINGS

For external use only.

When using this product

• use only as directed
• do not bandage tightly or use with a heating pad
• avoid contact with the eyes and mucous membranes
• do not apply to wounds or damaged skin

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
• skin irritation develops.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Glycerin, Sodium Polyacrylate, Dihydroxyaluminium Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, POVIDONE K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80

Directions

Directions

Adults and Children 12 years of age and older:

• Peel off protective backing and apply sticky side to affected area.
• Carefully remove backing from patch
• Should be used up to 8 hours
• Should be used no more than 3 times a day
• Children under 12 years of age: Consult a doctor.

Purpose

Topical Analgesic

Warnings

Keep out of reach of children.

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

COLD AND HOT MEDICATED 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-422
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TARTARIC ACID (UNII: W4888I119H)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
KAOLIN (UNII: 24H4NWX5CO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL 95% (UNII: 7528N5H79B)
POVIDONE K90 (UNII: RDH86HJV5Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-422-42	24 in 1 BOX	11/25/2024	12/30/2024
1		2 in 1 POUCH
1		8.5 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 52000-422-41	2 in 1 POUCH	11/25/2024	12/30/2024
2		8.5 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	11/25/2024	12/30/2024

Labeler - UNIVERSAL DISTRIBUTION CENTER, LLC (019180459)

Registrant - Koolcare Technology Co., Ltd (602479389)

Establishment
Name	Address	ID/FEI	Business Operations
Koolcare Technology Co., Ltd		602479389	manufacture(52000-422)

Revised: 12/2024

Document Id: 349e3be7-fbee-af53-e063-6294a90a3f1b

34390-5

Set id: c19aa620-401d-43c4-804c-3611cc39e9f2

Version: 4

Effective Time: 20241230