UNIVERSAL ICE COLD ANALGESIC- menthol gel

Universal Ice Cold Analgesic by

Drug Labeling and Warnings

Universal Ice Cold Analgesic by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Orchid Lifesciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Temporary relieves  of minor aches and pains in muscles and joints associated with

• arthritis
• simple backache
• strains
• bruises
• sports injuries
• sprains
• provides cooling penetrating relief

Warnings

For external use only

Do not use

• with other topical pain relievers
• with heating pads or heating devices
  

When using this product

• do not use in or near the eyes
• do not apply to wounds or damaged skin
• do not bandage tightly
  

Stop use and ask doctor if

• condition worsens
  
• symptoms last more than 7 days or clean up and occur again within a few days
• redness or irritation develops
  

If pregnant or breast-feeding,

• ask a health professional before use

Keep out of the reach of children

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

Directions

• clean affected area before applying product
  
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: ask a doctor

Other information

• store at controlled room temperature 20 to 25oC (68 to 77oF in a tightly closed container
• do not use, pour, spill or store near heat or open flame

Inactive ingredients

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

PRINCIPAL DISPLAY PANEL

ICE COLD
ANALGESIC GEL
8 FL.OZ (227 GRAM)

INGREDIENTS AND APPEARANCE

UNIVERSAL ICE COLD ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOMER 940 (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-105-01	227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/25/2020

Labeler - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Lifesciences		675474890	manufacture(52000-105)