HEALTH SMART BLUE ICE TOPICAL ANALGESIC- menthol and camphor gel 
Home Smart Products

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.

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Health Smart Blue Ice Topical Gel

Active Ingredients

Menthol             1.0%

Camphor            0.5%

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only. Avoid contact with eyes.

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

When using this product, do not

Do not use with heating devices or pads.

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

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

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

adults and children 2 years and over:

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

PRINCIPAL DISPLAY PANEL

HEALTH SMART BLUE ICE TOPICAL ANALGESIC GEL

NET WT.8 OZ (227g)

PRINCIPAL DISPLAY PANEL



HEALTH SMART BLUE ICE TOPICAL ANALGESIC 
menthol and camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-017-27127 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
2NDC:52862-017-28170 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
3NDC:52862-017-21170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
4NDC:52862-017-29227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
5NDC:52862-017-30300 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
6NDC:52862-017-26500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/02/2013
Labeler - Home Smart Products (161872676)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-017)

Revised: 2/2022
Document Id: d887934a-7949-54f1-e053-2a95a90af978
Set id: 106015f1-83d7-464c-b408-c1438d924eea
Version: 5
Effective Time: 20220221
 
Home Smart Products