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NDC 72933-0000-00 Arumacil 11; 928 mg/g; mg/g Details

Arumacil 11; 928 mg/g; mg/g

Arumacil 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	72933-0000
Product ID	72933-000_ce2bb87d-d18a-4a5b-e053-2a95a90a9014
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
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 72933-0000-00 (72933000000)

Pricing Information	N/A
NDC Package Code	72933-000-00
Billing NDC	72933000000
Package	1 JAR in 1 BOX (72933-000-00) / 7.5 g in 1 JAR
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 14c30cad-8745-4795-9612-302230b2614f 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

dimethicone, petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72933-000
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:72933-000-00	1 in 1 BOX	04/01/2019
1		7.5 g in 1 JAR; 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	04/01/2019

Labeler - Hyatt Life Sciences, Inc. (117495900)

Revised: 10/2021

Document Id: ce2bb87d-d18a-4a5b-e053-2a95a90a9014

Set id: 14c30cad-8745-4795-9612-302230b2614f

Version: 3

Effective Time: 20211012