Label: DERMASARRA- otc topical analgesic drug products lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61924-189-08 - Packager: DERMARITE INDUSTRIES, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 14, 2022
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
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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
- Directions:
- Other Infomation:
- Inactive Ingredients:
- BOXED WARNING (What is this?)
- DermaSarra Package Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
DERMASARRA
otc topical analgesic drug products lotionProduct 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)