HOT ICE SOOTHING ANALGESIC- camphor and menthol gel

Hot Ice Soothing Analgesic by

Drug Labeling and Warnings

Hot Ice Soothing Analgesic by is a Otc medication manufactured, distributed, or labeled by Quality Care Distributors LLC, Anicare Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients   

Menthol 1%

Camphor 0.5%   

Purpose

Topical analgesic

Uses   

for the temporary relief of minor aches and pains in muscles and joins 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 worsen
  
• symptoms last more than 7 days or clear up and occurs again with a few days
  
• redness or 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 way.

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 hyderoxy toluene, carbopol, colour brilliant blue, creasmer RH 40, disodium Edta, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide

Principal Display Panel

FamilyCare
ICE
COLD
ANALGESIC GEL
NET WT. 8 OZ. (227 g)

INGREDIENTS AND APPEARANCE

HOT ICE SOOTHING ANALGESIC 
camphor and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52271-159
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.27 g  in 227 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.14 g  in 227 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 934 (UNII: Z135WT9208)
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: 52271-159-00	227 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/21/2009

Labeler - Quality Care Distributors LLC (961937112)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd.		916837425	MANUFACTURE