BLUE ICE TOPICAL ANALGESIC- menthol and camphor gel

Blue Ice Topical Analgesic by

Drug Labeling and Warnings

Blue Ice Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by FOUR SEASONS TRADING INC, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Menthol             1.0%

Camphor            0.5%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor pains and aches of your muscles and joints associated with:

• Sports Injuries
• Sprains
• Arthritis
• Bruises

WARNINGS

Warnings

For external use only. Avoid contact with eyes.

ASK DOCTOR

Ask a doctor before use if you have cough associated with :

• smoking
• excessive phlegm
• asthma
• emphysema
• persistent or chronic cough

WHEN USING

When using this product, do not

• heat
• microwave
• add to hot water or any container where heating water may cause splattering and result in burns
• use in eyes or directly on mucous membranes
• take by mouth or place in nostrils
• apply to wounds or damaged skin
• bandage skin

DO NOT USE

Do not use with heating devices or pads.

STOP USE

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

• apply to the affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician.

INACTIVE INGREDIENT

Inactive Ingredients

Aqua, Isopropyl Alcohol, Propylene Glycol, Carbopol, PEG-40 Hydrogenated Castor Oil, Sodium Hydroxide , Disodium EDTA, Benzyl Alcohol, BHT & FD&C Blue No.1

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

BLUE ICE TOPICAL ANALGESIC GEL

NET WT. 8 OZ (227g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLUE ICE TOPICAL ANALGESIC 
menthol and camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69274-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69274-004-15	127 g in 1 TUBE
2	NDC: 69274-004-16	170 g in 1 TUBE
3	NDC: 69274-004-13	170 g in 1 BOTTLE, PLASTIC
4	NDC: 69274-004-17	227 g in 1 BOTTLE, PLASTIC
5	NDC: 69274-004-18	300 g in 1 BOTTLE, PLASTIC
6	NDC: 69274-004-19	500 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/25/2014

Labeler - FOUR SEASONS TRADING INC (169331464)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(69274-004)