HEALTH SMART BLUE ICE TOPICAL ANALGESIC- menthol and camphor gel

Health Smart Blue Ice Topical Analgesic by

Drug Labeling and Warnings

Health Smart Blue Ice Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Home Smart Products, 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

HEALTH SMART BLUE ICE TOPICAL ANALGESIC GEL

NET WT.8 OZ (227g)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTH SMART BLUE ICE TOPICAL ANALGESIC 
menthol and camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-017
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)	0.5 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: 52862-017-27	127 g in 1 TUBE
2	NDC: 52862-017-28	170 g in 1 TUBE
3	NDC: 52862-017-21	170 g in 1 BOTTLE, PLASTIC
4	NDC: 52862-017-29	227 g in 1 BOTTLE, PLASTIC
5	NDC: 52862-017-30	300 g in 1 BOTTLE, PLASTIC
6	NDC: 52862-017-26	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	10/02/2013

Labeler - Home Smart Products (161872676)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(52862-017)