Drug Labeling and Warnings

Drug Details

k">

THERASEPTIN- zinc oxide, menthol ointment 
Cal Pharma

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.

----------

ZINC OXIDE 20.6%

MENTHOL 0.50%

SKIN PROTECTANT

EXTERNAL ANALGESIC/ANTI-ITCH

USES: AMOISTURE BARRIER THAT PREVENTS AND HELPS HEAL SKIN IRRITATIONS FROM: URINE, DIARRHEA, PERSPIRATION, FISTULA, DRAINAGE, FEEDING TUBE SITE LEAKAGE, WOUND DRAINAGE (PERI-WOUND SKIN), MINOR BURNS, CUTS, SCRAPES, ITCHING

WARNINGS: FOR EXTERNAL USE ONLY

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

Not for use on deep or puncture wounds.

Stop use and ask a doctor if condition worsens or does not improve within 7 days.

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

Directions: Cleanse skin with mild skin cleanser. Apply to affected area 2-4 times daily, or after each incontinent episode to promote comfort and long lasting protection.

Inactive Ingredients: Butyrospermum Parkii (Shea Butter), Cera Alba, Calamine, Cetearyl Alcohol, Chlorothymol, Cocos Nucifera(Coconut) Oil, Glyceryl Stearate and PEG 100 Stearate, Hydrogenated Polyisobutene, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mineral Oil, Petrolatum, Phenol, Phenoxyethanol (and) Benzoic Acid (and) Ethylhexyglycerin (and) Glycereth-2 Cocoate Propylene Glycol, Ricinus Communis (Castor) Seed Oil,Tapioca Starch (and) Polymethylsilsesquioxane Theobroma Cacao (Cocoa) Seed Butter, Thymol.

TheraSEPTIN-14 FINAL

THERASEPTIN 
zinc oxide, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55628-9204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROTHYMOL (UNII: LJ25TI0CVT)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
LANOLIN (UNII: 7EV65EAW6H)  
TEA TREE OIL (UNII: VIF565UC2G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOL (UNII: 339NCG44TV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CASTOR OIL (UNII: D5340Y2I9G)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
THYMOL (UNII: 3J50XA376E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55628-9204-4120 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/29/2012
Labeler - Cal Pharma (078721283)

Revised: 2/2013
 
Cal Pharma


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.