DERMASARRA- otc topical analgesic drug products lotion

DERMASARRA by

Drug Labeling and Warnings

DERMASARRA by is a Otc medication manufactured, distributed, or labeled by DERMARITE INDUSTRIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

BOXED WARNING

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Questions?

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

Labeler - DERMARITE INDUSTRIES, LLC (883925562)

Registrant - DERMARITE INDUSTRIES, LLC (883925562)

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