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Ice Cold Analgesic by North & South Wholesalers LLC

Dosage form: gel
Ingredients: MENTHOL 1g in 100g, CAMPHOR (SYNTHETIC) 0.5g in 100g
Labeler: North & South Wholesalers LLC
NDC Code: 70201-003

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.

Ice Cold Analgesic Gel

Active Ingredients

Menthol             1%

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 a 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 hydroxy toluene, carbopol, color brilient blue, creasmer RH-40, disodium EDTA, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide.

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

ICE COLD ANALGESIC 
menthol,camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70201-003
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 HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) 
BRILLANT BLUE 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
EDETATE DISODIUM 
ISOPROPYL ALCOHOL 
PROPYLENE GLYCOL 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:70201-003-08227 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/03/2015
Labeler - North & South Wholesalers LLC (004948495)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(70201-003)

Revised: 11/2015
 
North & South Wholesalers LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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