Search by Drug Name or NDC

NDC 72933-0006-01 Arumacil Protectant Cold Sore 11; 928 mg/g; mg/g Details

Arumacil Protectant Cold Sore 11; 928 mg/g; mg/g

Arumacil Protectant Cold Sore is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Hyatt Life Sciences, Inc.. The primary component is DIMETHICONE; PETROLATUM.

Product Information

NDC	72933-0006
Product ID	72933-006_b7b38985-a96c-22c5-e053-2995a90a3f9c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Arumacil Protectant Cold Sore
Proprietary Name Suffix	n/a
Non-Proprietary Name	DIMETHICONE, PETROLATUM
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	11; 928
Active Ingredient Units	mg/g; mg/g
Substance Name	DIMETHICONE; PETROLATUM
Labeler Name	Hyatt Life Sciences, Inc.
Pharmaceutical Class	Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 72933-0006-01 (72933000601)

Pricing Information	N/A
NDC Package Code	72933-006-01
Billing NDC	72933000601
Package	1 TUBE in 1 BLISTER PACK (72933-006-01) / 7.5 g in 1 TUBE
Marketing Start Date	2020-12-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b7b38985-a96b-22c5-e053-2995a90a3f9c Details

Drug Facts

Active ingredients

Dimethicone 1.1%

Petrolatum 92.8%

Purpose

Skin Protectant

Use

relieves dryness and softens cold sores and fever blisters

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

apply as needed

Inactive ingredients

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ARUMACIL PROTECTANT COLD SORE

dimethicone, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72933-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	11 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	928 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ARUM PALAESTINUM WHOLE (UNII: 4E96UIB20M)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
TURMERIC (UNII: 856YO1Z64F)
VANILLIN (UNII: CHI530446X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72933-006-01	1 in 1 BLISTER PACK	12/30/2020
1		7.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/30/2020

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