Pain Relief Therapy Patch 5 ct. (Large) 700238, 2020

Hot and Cold by

Drug Labeling and Warnings

Hot and Cold by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HOT AND COLD- menthol patch 
United Exchange Corp

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pain Relief Therapy Patch 5 ct. (Large) 700238, 2020

Active ingredient Purpose

Menthol 5%................................................................................Topical analgesic

Uses Temporarily relieves minor pain associated with:

• arthritis
• simple backache
• bursitis
• tendonitis
• muscle strains
• muscle sprains
• bruises
• cramps
  

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 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
  

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 over 12 years:

• carefully peel off protective backing
• apply sticky side to affected area
• wear one patch up to 8 hours
• repeat as necessary but no more than 3 times daily

children 12 years or younger:

• consult a doctor

Other information

• store at room temperature, not to exceed 86°F (30°C)
  

Inactive ingredients 1,3-butylene glycol, aloe vera, BHT, d-sorbitol, disodium edetate, gelatin, glycerine, kaolin, liquid paraffin, magnesium aluminum hydrate, methacrylic acid butylacrylate copolymer, methyl parahydroxybenzoate, polysorbate 80, purified water, sodium metaphosphate, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, tocopherol acetate

Distributed By:

United Exchange Corp

5836 Corporate Ave.

Cypress CA 90630

Made in Korea

HOT AND COLD 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PARAFFIN (UNII: I9O0E3H2ZE)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GELATIN (UNII: 2G86QN327L)
KAOLIN (UNII: 24H4NWX5CO)
MAGALDRATE (UNII: 6V88E24N5T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
TARTARIC ACID (UNII: W4888I119H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-705-05	5 in 1 POUCH	08/28/2020
1		1 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 not final	part348	08/28/2020	10/21/2021

Labeler - United Exchange Corp (840130579)

Revised: 12/2021

Document Id: d297eac2-9e57-5ed1-e053-2a95a90adb6e

34390-5

Set id: adf2e146-4024-f232-e053-2995a90a8c87

Version: 3

Effective Time: 20211207