ISOPROPYL RUBBING ALCOHOL 99% 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.

----------

HEALTH SMART ISOPROPYL RUBBING ALCOHOL 91% WITH WINTERGREEN

Active ingredient (by volume)

Isopropyl alcohol (99% 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 99% WITH WINTERGREEN

TOPICAL ANTIMICROBIAL

12 FL.OZ (354 mL)

Label

ISOPROPYL RUBBING ALCOHOL 99% WITH WINTERGREEN 
isopropyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 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:52862-029-01119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
2NDC:52862-029-02178 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/18/2020
Labeler - Home Smart Products (161872676)
Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
Establishment
NameAddressID/FEIBusiness Operations
Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(52862-029)

Revised: 11/2021
Document Id: d198ce47-532a-47fa-e053-2a95a90ab18f
Set id: d196bef3-625a-b7d5-e053-2995a90afe6c
Version: 2
Effective Time: 20211125
 
Home Smart Products