THERASEPTIN

Manufacturer: Cal Pharma
Effective date: 2019-11-23
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:57:35

Label at a glance#

ProductTHERASEPTIN

Active ingredientZINC OXIDE, MENTHOL

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 20.6%

MENTHOL 0.50%

OTC - PURPOSE SECTION

SKIN PROTECTANT

EXTERNAL ANALGESIC/ANTI-ITCH

INDICATIONS & USAGE SECTION

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 SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TheraSEPTIN-14 FINAL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55628-9204-4	2024-04-01	C162847	48780-1	d6a99b39-6b35-a426-e053-dadaa90af4c2	7d4ff7f7-1147-4eee-80f4-536089af9ed1
55628-9204-4	2022-01-28	C162847	48780-1	d6a99b39-6b35-a426-e053-dadaa90af4c2	7d4ff7f7-1147-4eee-80f4-536089af9ed1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CHLOROTHYMOL	INACTIVE INGREDIENT	LJ25TI0CVT	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	1
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
GLYCERETH-2 COCOATE	INACTIVE INGREDIENT	JWM00VS7HC	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYDROGENATED POLYBUTENE (1300 MW)	INACTIVE INGREDIENT	7D1YQ9Y5EZ	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYMETHYLSILSESQUIOXANE (11 MICRONS)	INACTIVE INGREDIENT	Z570VEV8XK	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1
THEOBROMA GRANDIFLORUM SEED BUTTER	INACTIVE INGREDIENT	I711F13FXM	1
THYMOL	INACTIVE INGREDIENT	3J50XA376E	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

THERASEPTIN
ZINC OXIDE, MENTHOL
ZINC OXIDE
MENTHOL
SHEA BUTTER
YELLOW WAX
FERRIC OXIDE RED
CETOSTEARYL ALCOHOL
CHLOROTHYMOL
COCONUT OIL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
HYDROGENATED POLYBUTENE (1300 MW)
LANOLIN
TEA TREE OIL
MINERAL OIL
PETROLATUM
PHENOL
PHENOXYETHANOL
BENZOIC ACID
ETHYLHEXYLGLYCERIN
GLYCERETH-2 COCOATE
PROPYLENE GLYCOL
CASTOR OIL
STARCH, TAPIOCA
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
THEOBROMA GRANDIFLORUM SEED BUTTER
THYMOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55628-9204	55628-9204-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
SHEA BUTTER	K49155WL9Y	IACT
YELLOW WAX	2ZA36H0S2V	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CHLOROTHYMOL	LJ25TI0CVT	IACT
COCONUT OIL	Q9L0O73W7L	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
PEG-100 STEARATE	YD01N1999R	IACT
HYDROGENATED POLYBUTENE (1300 MW)	7D1YQ9Y5EZ	IACT
LANOLIN	7EV65EAW6H	IACT
TEA TREE OIL	VIF565UC2G	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
PHENOL	339NCG44TV	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLYCERETH-2 COCOATE	JWM00VS7HC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CASTOR OIL	D5340Y2I9G	IACT
STARCH, TAPIOCA	24SC3U704I	IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)	Z570VEV8XK	IACT
THEOBROMA GRANDIFLORUM SEED BUTTER	I711F13FXM	IACT
THYMOL	3J50XA376E	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 276 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	TABLET / ORAL	5 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	DOUCHE / VAGINAL	0.14 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, EXTENDED RELEASE / ORAL	23.27 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	SOLUTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	CAPSULE / ORAL	100 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CREAM / TOPICAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRA-ARTICULAR	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION, SOLUTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CONCENTRATE / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, DELAYED RELEASE / ORAL		37 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / SUBLINGUAL	1.23 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	LIQUID / SUBCUTANEOUS	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, SOLUTION / INTRAMUSCULAR		75 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
150e3b3f-75e1-7554-e063-6394a90ab7a4			7d4ff7f7-1147-4eee-80f4-536089af9ed1	2024-04-01	Warnings	Exact identifier spl set id: 7d4ff7f7-1147-4eee-80f4-536089af9ed1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.