CALAMICARE- calamine lotion 
Innovus Pharmaceuticals, Inc.

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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Calamine Lotion

Active ingredients

Calamine 8% and Zinc Oxide 8%

Purpose

Skin protectant

Uses

Dries the oozing and weeping of poison: ivy, oak, sumac

Warnings

For external use only

When using this product

do not get into eyes

Stop use and ask a doctor if

  • condition worsens 
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children 

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before using
  • apply as needed

Other Information

Store at 15-25C (59-77F)

Inactive ingredients

Glycerin, microcrystalline cellulose and carboxymethylcellulose
sodium (Avicel RC 591), phenol (liquified), purified water , sodium citrate

CalamiCare Calamine Topical Suspension

image description

CALAMICARE 
calamine lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PHENOL (UNII: 339NCG44TV)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57483-200-06200 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/202201/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/04/202201/04/2022
Labeler - Innovus Pharmaceuticals, Inc. (962507187)
Establishment
NameAddressID/FEIBusiness Operations
AMMAN PHARMACEUTICAL INDUSTRIES534677849manufacture(57483-200)

Revised: 1/2023
Document Id: c068167c-5e50-4587-a6c9-dce72d30d002
Set id: 194be217-0d1d-441c-af0f-59c8291c7854
Version: 2
Effective Time: 20230113
 
Innovus Pharmaceuticals, Inc.