ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN- isopropyl alcohol liquid 
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 ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN

Active ingredient (by volume)

Isopropyl alcohol (50% concentrate)

Purpose

topical antimicrobial

Uses

Warnings

For external use only

Ask a doctor before use if you have deep puncture wounds or serious burns

When using this product

Stop use and ask a doctor if condition persists or gets worse

Keep out of reach of children.

In case of an accidental ingestion, contact a Poison Control Center immediately

Directions

Other information

Inactive ingredient

Water, methyl salicylate, laneth-75, FD&C Blue #1, FD&C Yellow #5

PRINCIPAL DISPLAY PANEL

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

alcohol-wintergreen-50

ISOPROPYL RUBBING ALCOHOL WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
PEG-75 LANOLIN (UNII: 09179OX7TB)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52862-006-03119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
2NDC:52862-006-04178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
3NDC:52862-006-06237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
4NDC:52862-006-09295 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
5NDC:52862-006-10354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
6NDC:52862-006-11414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
7NDC:52862-006-12473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/08/2012
Labeler - Home Smart Products (161872676)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52862-006)

Revised: 12/2018
Document Id: 7e17a12c-fe37-c8ea-e053-2a91aa0a118f
Set id: 147174c2-854d-4fb7-b09e-2c70346a1790
Version: 2
Effective Time: 20181228
 
Home Smart Products