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NDC 61924-0189-08 DERMASARRA 0.005 g/mL Details

DERMASARRA 0.005 g/mL

DERMASARRA is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by DERMARITE INDUSTRIES, LLC. The primary component is CAMPHOR (NATURAL).

Product Information

NDC	61924-0189
Product ID	61924-189_d58c8d23-4797-535b-e053-2a95a90ab26f
Associated GPIs
GCN Sequence Number	081429
GCN Sequence Number Description	camphor LOTION 0.5 % TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	48535
HICL Sequence Number	002617
HICL Sequence Number Description	CAMPHOR
Brand/Generic	Brand
Proprietary Name	DERMASARRA
Proprietary Name Suffix	n/a
Non-Proprietary Name	OTC TOPICAL ANALGESIC DRUG PRODUCTS
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	0.005
Active Ingredient Units	g/mL
Substance Name	CAMPHOR (NATURAL)
Labeler Name	DERMARITE INDUSTRIES, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61924-0189-08 (61924018908)

Pricing Information	N/A
NDC Package Code	61924-189-08
Billing NDC	61924018908
Package	222 mL in 1 BOTTLE, PUMP (61924-189-08)
Marketing Start Date	2010-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1fad8650-8bd6-4711-9121-b9f6ff8bdf6b Details

Active Ingredient

Camphor 0.5%

Purpose

External Analgesic

Uses:

Temporary relief of itching associiated with minor skin irritations due to:

dry skin
insect bites
detergent
sunburn

Warnings:

For external use only.
Avoid contact with eyes. In case of contact, flush thoroughly with water.
Stop use and ask a doctor if, condition worsens, symptoms last for more than 7 days, symptoms clear up and occur again within a few days
Do not use on deep puncture wounds, animal bites, or serious burns.

Warnings

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away

Directions:

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times dialy,

Children under 2 years of age: Consult a doctor

Other Infomation:

Store at room temperature (59°-86°F)

You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

water, Cetearyl Alcohol, PEG-40 Castor Oil, Sodium Cetearyl Sulfate, Stearic Acid, Glycol Stearate, Mineral Oil, Dimethicone, PEG-4 Dilaurate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Titanium Dioxide, menthol, Carbomer, Petrolatum, Disodium EDTA

WARNING

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

DermaSarra Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMASARRA

otc topical analgesic drug products lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61924-189
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.005 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
IMIDUREA (UNII: M629807ATL)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCOL STEARATE (UNII: 0324G66D0E)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PEG-4 DILAURATE (UNII: KCR71CW036)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
MENTHOL (UNII: L7T10EIP3A)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61924-189-08	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/24/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/24/2010

Labeler - DERMARITE INDUSTRIES, LLC (883925562)

Registrant - DERMARITE INDUSTRIES, LLC (883925562)

Name	Address	ID/FEI	Business Operations
Establishment
DERMARITE INDUSTRIES, LLC		883925562	manufacture(61924-189)

Revised: 1/2022

Document Id: d58c8d23-4797-535b-e053-2a95a90ab26f

Set id: 1fad8650-8bd6-4711-9121-b9f6ff8bdf6b

Version: 6

Effective Time: 20220114