EL VALLE DECOLORIZED IODINE- alcohol tincture 
Pharmadel LLC

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.

----------

El Valle Decolorized Iodine (Alcohol 48%)

Drug Facts

Drug facts

Active Ingredient & Purpose

Gentian Violet 1%

Active ingredientPurpose
Alcohol 48% .............................First aid antiseptic

Uses

First aid to help prevent infection in

Warnings

FOR EXTERNAL USE ONLY.

Do not use

  • longer than 1 week, unless directed by a doctor
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • a deep or puncture wounds
  • serious burns
  • animal bites

Stop use and consult a doctor if

  • conditions persist or gets worse

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

ammonia, iodine, sodium iodide, water

Prinicpal Display Panel

PDP D IODINE

EL VALLE DECOLORIZED IODINE 
alcohol tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-374
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.48 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIA (UNII: 5138Q19F1X)  
WATER (UNII: 059QF0KO0R)  
SODIUM IODIDE (UNII: F5WR8N145C)  
IODINE (UNII: 9679TC07X4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-374-0115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/202305/31/2023
2NDC:55758-374-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2023
Labeler - Pharmadel LLC (030129680)

Revised: 6/2023
Document Id: fe1d860a-1ca5-c800-e053-6394a90abd03
Set id: fd7a227b-536c-b3f7-e053-6394a90a4158
Version: 2
Effective Time: 20230614
 
Pharmadel LLC