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NDC 61924-0174-08 DermaCerin 33 g/100g Details

DermaCerin 33 g/100g

DermaCerin is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by DermaRite Industries, LLC. The primary component is PETROLATUM.

Product Information

NDC	61924-0174
Product ID	61924-174_d58c6a28-840c-4f4b-e053-2a95a90a8187
Associated GPIs
GCN Sequence Number	005349
GCN Sequence Number Description	mineral oil/petrolatum,white CREAM (G) TOPICAL
HIC3	L2A
HIC3 Description	EMOLLIENTS
GCN	77729
HICL Sequence Number	002215
HICL Sequence Number Description	MINERAL OIL/PETROLATUM,WHITE
Brand/Generic	Generic
Proprietary Name	DermaCerin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Skin Protectant
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	33
Active Ingredient Units	g/100g
Substance Name	PETROLATUM
Labeler Name	DermaRite Industries, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61924-0174-08 (61924017408)

Pricing Information	N/A
NDC Package Code	61924-174-08
Billing NDC	61924017408
Package	198 g in 1 TUBE (61924-174-08)
Marketing Start Date	2016-10-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4 Details

Active Ingredient:

Petrolatum 33%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve dry, chapped, or cracked skin.
Helps protect skin from the drying effects of wind and cold weather.

Warnings:

For external use only.

Avoid contact with eyes. In case of contact, flush thoroughly with water

Warnings:

Stop and ask a doctor if

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

Warnings:

Do not use on deep or puncture wounds, animal bites, or serious wounds.

Warnings:

Keep out of reach of children.

In case of accidental ingestion contact a Physician or Poison Control Center right away.

Directions:

Apply as needed or as directed by a physician.

Other Information:

Store at room temperature (59º- 86ºF)
You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047.

Inactive ingredients:

Water, Mineral Oil, Paraffin, Lanolin Alcohol, PEG-30 Dipolhydroxystearate, DMDM Hydantoin, Methylparaben, Propylparaben, Propylene Glycol, Sodium Chloride

Questions?

Call 800-337-6296 Mon - Fri 9AM - 5PM EST.

DermaCerin Package Label and Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMACERIN

skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61924-174
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	33 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLENE GLYCOL 2-(2-METHYLBUTYRATE) (UNII: 3Z73C506A9)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61924-174-04	106 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
2	NDC:61924-174-08	198 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
3	NDC:61924-174-16	454 g in 1 JAR; Type 0: Not a Combination Product	10/17/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/17/2016

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Name	Address	ID/FEI	Business Operations
Establishment
DermaRite Industries, LLC		883925562	manufacture(61924-174)

Revised: 1/2022

Document Id: d58c6a28-840c-4f4b-e053-2a95a90a8187

Set id: 5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4

Version: 3

Effective Time: 20220114

Search by Drug Name or NDC

NDC 61924-0174-08 DermaCerin 33 g/100g Details

DermaCerin 33 g/100g

Product Information

Package

Package Images

NDC 61924-0174-08 (61924017408)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4 Details

Active Ingredient:

Purpose:

Uses:

Warnings:

Warnings:

Warnings:

Warnings:

Directions:

Other Information:

Inactive ingredients:

Questions?

DermaCerin Package Label and Principal Display Panel

INGREDIENTS AND APPEARANCE

Plavix (Clopidogrel) With Olive Oil Dosing Question

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Search by Drug Name or NDC

NDC 61924-0174-08 DermaCerin 33 g/100g Details

DermaCerin 33 g/100g

Product Information

Package

Package Images

NDC 61924-0174-08 (61924017408)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4 Details

Active Ingredient:

Purpose:

Uses:

Warnings:

Warnings:

Warnings:

Warnings:

​Directions:

Other Information:

Inactive ingredients:

​Questions?

DermaCerin Package Label and Principal Display Panel

INGREDIENTS AND APPEARANCE

Directions:

Questions?