ARUMACIL PROTECTANT COLD SORE- dimethicone, petrolatum ointment 
Hyatt Life Sciences, 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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Arumacil Protectant Cold Sore Ointment

Drug Facts

Active ingredients 

Dimethicone 1.1%

Petrolatum 92.8%

Purpose

Skin Protectant

Use

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

Do not use on

  • deep or puncture wounds 
  • animal bites
  • serious burns

Keep out of reach of children.

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

Directions

Inactive ingredients

Arum Palaestinum, Beta-Sitosterol, Peganum Harmala, Turmeric, Vanillin, Vitamin C

Package Labeling:

Outer LabelInner Label

ARUMACIL PROTECTANT COLD SORE 
dimethicone, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72933-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE11 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM928 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ARUM PALAESTINUM WHOLE (UNII: 4E96UIB20M)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
TURMERIC (UNII: 856YO1Z64F)  
VANILLIN (UNII: CHI530446X)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72933-006-011 in 1 BLISTER PACK12/30/2020
17.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/30/2020
Labeler - Hyatt Life Sciences, Inc. (117495900)

Revised: 1/2021
Document Id: b7b38985-a96c-22c5-e053-2995a90a3f9c
Set id: b7b38985-a96b-22c5-e053-2995a90a3f9c
Version: 1
Effective Time: 20210108
 
Hyatt Life Sciences, Inc.