Your browser does not support JavaScript! ICE COLD ANALGESIC GEL (MENTHOL AND CAMPHOR) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]
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ICE COLD ANALGESIC GEL (menthol and camphor) gel
[Universal Distribution Center LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients

Menthol             1.0%

Camphor            0.5%

Purpose

Topical Analgesic

Uses

for the temporary relief  of minor aches and pains in muscles and joints associated with:

  • simple backache
  • strains
  • sprains
  • sports injuries
  • arthritis
  • bruises

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 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

Inactive ingredients

benzyl alcohol, butylated hydroxytoluene, carbopol, colour brillient blue, creasmer RH 40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water and sodium hydroxide

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic
NET WT.8 OZ (227g)

PRINCIPAL DISPLAY PANEL



ICE COLD ANALGESIC GEL 
menthol and camphor gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52000-013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
CARBOMER 934 
FD&C BLUE NO. 1 
EDETATE DISODIUM 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-013-17127 g in 1 TUBE
2NDC:52000-013-18170 g in 1 TUBE
3NDC:52000-013-13170 g in 1 BOTTLE, PLASTIC
4NDC:52000-013-14227 g in 1 BOTTLE, PLASTIC
5NDC:52000-013-15300 g in 1 BOTTLE, PLASTIC
6NDC:52000-013-16500 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/15/2013
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-013)

Revised: 3/2013
 
Universal Distribution Center LLC

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