BLISTEX LIP OINTMENT
- Manufacturer
- HART Health
- Effective date
- 2024-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:43
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients:
Dimethicone 1.1% (w/w)
Camphor 0.5% (w/w)
Menthol 0.6% (w/w)
Phenol 0.5% (w/w)
OTC - PURPOSE SECTION
Purpose:
Skin protectant
External analgesic
External analgesic
External analgesic
INDICATIONS & USAGE SECTION
Uses: for the temporary protection and relief of pain and itching associated with
- minor lip irritation
- chapped or cracked lips
- cold sores
WARNINGS SECTION
Warnings: For external use only
OTC - DO NOT USE SECTION
Do not use
- in the eyes or over large portions of the body
- on deep or puncture wounds
- on animal bites
- on serious burns
OTC - STOP USE SECTION
Stop use and ask a doctor if
- condition worsens
- condition lasts for more than 7 days
- symptoms clear up and occur again within a few days
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions
Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily
Children under 2 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1358989 | camphor 0.5 % / dimethicone 1.1 % / menthol 0.6 % / phenol 0.5 % Topical Ointment | PSN | 4 |
| 1358989 | camphor 0.005 MG/MG / dimethicone 0.011 MG/MG / menthol 0.006 MG/MG / phenol 0.005 MG/MG Topical Ointment | SCD | 4 |
| 1358989 | camphor 0.5 % / dimethicone 1.1 % / menthol 0.6 % / phenol 0.5 % Topical Ointment | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIMETHICONE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50332-0029-2 | 2024-02-15 | C162847 | 48780-1 | 9855d018-d763-cd31-e053-dbdaa90ab51a | BLISTEX LIP OINTMENT |
| 50332-0029-2 | 2019-11-27 | C162847 | 48780-1 | 9855d018-d763-cd31-e053-dbdaa90ab51a | BLISTEX LIP OINTMENT |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50332-0028-2 | Blistex Lip | .5 g in 1 PACKET | OINTMENT | .5 | 4 | |
| 50332-0028-2 | Blistex Lip | 25 in 1 BOX, UNIT-DOSE | OINTMENT | 25 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0028 | BLISTEX LIP (DIMETHICONE, CAMPHOR, MENTHOL, PHENOL) OINTMENT [HART HEALTH] | 4 | 2 package rows | 20240217_63300820-80ca-432f-b86d-ef15d878671b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAMPHOR OIL | ACTIVE INGREDIENT | 75IZZ8Y727 | 1 | |
| DIMETHICONE | ACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| PHENOL | ACTIVE INGREDIENT | 339NCG44TV | 1 | |
| CAMPHOR OIL | ACTIVE MOIETY | 75IZZ8Y727 | 1 | |
| DIMETHICONE | ACTIVE MOIETY | 92RU3N3Y1O | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| PHENOL | ACTIVE MOIETY | 339NCG44TV | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| CALCIUM HYDROXIDE | INACTIVE INGREDIENT | PF5DZW74VN | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| EDETATE CALCIUM DISODIUM | INACTIVE INGREDIENT | 25IH6R4SGF | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| LAURIC ACID | INACTIVE INGREDIENT | 1160N9NU9U | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| MYRISTIC ACID | INACTIVE INGREDIENT | 0I3V7S25AW | 1 | |
| OLEIC ACID | INACTIVE INGREDIENT | 2UMI9U37CP | 1 | |
| PALMITIC ACID | INACTIVE INGREDIENT | 2V16EO95H1 | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| POLYGLYCERYL-3 DIISOSTEARATE | INACTIVE INGREDIENT | 46P231IQV8 | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Blistex Lip
- dimethicone, camphor, menthol, phenol
- DIMETHICONE
- CAMPHOR OIL
- MENTHOL
- PHENOL
- ALLANTOIN
- EDETATE CALCIUM DISODIUM
- CALCIUM HYDROXIDE
- CETYL ALCOHOL
- GLYCERIN
- LANOLIN
- LAURIC ACID
- MINERAL OIL
- MYRISTIC ACID
- OLEIC ACID
- PALMITIC ACID
- PARAFFIN
- PETROLATUM
- POLYGLYCERYL-3 DIISOSTEARATE
- POTASSIUM HYDROXIDE
- WATER
- SODIUM HYDROXIDE
- STEARYL ALCOHOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0028 | 50332-0028-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | ACTIB |
| CAMPHOR OIL | 75IZZ8Y727 | ACTIB |
| MENTHOL | L7T10EIP3A | ACTIB |
| PHENOL | 339NCG44TV | ACTIB |
| ALLANTOIN | 344S277G0Z | IACT |
| EDETATE CALCIUM DISODIUM | 25IH6R4SGF | IACT |
| CALCIUM HYDROXIDE | PF5DZW74VN | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LANOLIN | 7EV65EAW6H | IACT |
| LAURIC ACID | 1160N9NU9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| MYRISTIC ACID | 0I3V7S25AW | IACT |
| OLEIC ACID | 2UMI9U37CP | IACT |
| PALMITIC ACID | 2V16EO95H1 | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYGLYCERYL-3 DIISOSTEARATE | 46P231IQV8 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | OINTMENT, AUGMENTED / TOPICAL | 0.11 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE / ORAL | 172 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CAPSULE, DELAYED RELEASE / ORAL | 59 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 136.55 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / AURICULAR (OTIC) | 0.8 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OIL / TOPICAL | 43.29 %v/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVENOUS | 456 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRADERMAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / TOPICAL | 162000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / PARENTERAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, FILM COATED / ORAL | 8 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / TOPICAL | 70 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVITREAL | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 78.36 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPONGE / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRASPINAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CREAM / VAGINAL | 3 mg | ||
| OLEIC ACID | OLEIC ACID | 2UMI9U37CP | CAPSULE / ORAL | 8759 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | AEROSOL, METERED / RESPIRATORY (INHALATION) | ADJ PH | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | JELLY / TOPICAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SUPPOSITORY / VAGINAL | 27 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / OPHTHALMIC | 6 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | INJECTION / INTRAVENOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| POTASSIUM HYDROXIDE | POTASSIUM HYDROXIDE | WZH3C48M4T | CAPSULE, EXTENDED RELEASE / ORAL | 0.07 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / TOPICAL | 39 mg | ||
| EDETATE CALCIUM DISODIUM | EDETATE CALCIUM DISODIUM | 25IH6R4SGF | POWDER, FOR SUSPENSION / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| EDETATE CALCIUM DISODIUM | EDETATE CALCIUM DISODIUM | 25IH6R4SGF | CAPSULE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| EDETATE CALCIUM DISODIUM | EDETATE CALCIUM DISODIUM | 25IH6R4SGF | INJECTION, SOLUTION / SUBCUTANEOUS | 0.06 %w/v | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| CALCIUM HYDROXIDE | CALCIUM HYDROXIDE | PF5DZW74VN | INJECTION / INTRAVENOUS | 3.7 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / SUBMUCOSAL | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7dd5b472-551f-4bb3-abcb-b53e5fa23497 | 63300820-80ca-432f-b86d-ef15d878671b | 2024-01-18 | Warnings | 7dd5b472-551f-4bb3-abcb-b53e5fa23497 63300820-80ca-432f-b86d-ef15d878671b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
