WARNINGS SECTION
For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to open wounds. STOP USE AND ask a doctor if condition worsens or symptoms persist for more than seven days, discontinue use of the product.
For external use only. Avoid contact with eyes. Keep out of reach of children. Do not apply to open wounds. STOP USE AND ask a doctor if condition worsens or symptoms persist for more than seven days, discontinue use of the product.
Adults and children two years of age and older, apply to affected area not more than three times daily or as directed by a doctor. Consult a physician for children under the age of two.
Butylene Glycol,
Caprylyl Glycol,
Dehydroacetic Acid,
Ethylhexylglycerin,
Glycine,
Hexylene Glycol,
Malic Acid,
Phenoxyethanol,
Purified Water,
Strontium Chloride Hexahydrate,
Xanthan Gum.
Astringent
For external use only.
Avoid contact with eyes.
Keep out of reach of children.
Do not apply to open wounds.
STOP USE AND ask a doctor if condition worsens or
symptoms persist for more than seven days, discontinue
use of the product.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 35192-005-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d63a-f424-e053-dadaa90a57ce | Hydrogel Formulated with COSMEDERM7 For temporary Relief of Minor Itching and Burning |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35192-005-04 | Astringent | 4 mL in 1 POUCH | GEL | 4 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALUMINUM ACETATE | ACTIVE INGREDIENT | 80EHD8I43D | 1 | |
| ALUMINUM CATION | ACTIVE MOIETY | 3XHB1D032B | 1 | |
| Butylene Glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Dehydroacetic Acid | INACTIVE INGREDIENT | 2KAG279R6R | 1 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| Glycine | INACTIVE INGREDIENT | TE7660XO1C | 1 | |
| Hexylene Glycol | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| Malic Acid | INACTIVE INGREDIENT | 817L1N4CKP | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Strontium Chloride Hexahydrate | INACTIVE INGREDIENT | O09USB7Z44 | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 35192-005 | 35192-005-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALUMINUM ACETATE | 80EHD8I43D | ACTIB |
| Butylene Glycol | 3XUS85K0RA | IACT |
| Caprylyl Glycol | 00YIU5438U | IACT |
| Dehydroacetic Acid | 2KAG279R6R | IACT |
| Ethylhexylglycerin | 147D247K3P | IACT |
| Glycine | TE7660XO1C | IACT |
| Hexylene Glycol | KEH0A3F75J | IACT |
| Malic Acid | 817L1N4CKP | IACT |
| Phenoxyethanol | HIE492ZZ3T | IACT |
| Water | 059QF0KO0R | IACT |
| Strontium Chloride Hexahydrate | O09USB7Z44 | IACT |
| Xanthan Gum | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | OINTMENT / TOPICAL | 12 %w/w | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, SOLUTION / INTRAVENOUS | 0.42 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION / ORAL | 450 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | TABLET / ORAL | 20 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Dehydroacetic Acid | DEHYDROACETIC ACID | 2KAG279R6R | LOTION / TOPICAL | 1 mg | ||
| Glycine | GLYCINE | TE7660XO1C | TABLET, CHEWABLE / ORAL | 267 mg | ||
| Dehydroacetic Acid | DEHYDROACETIC ACID | 2KAG279R6R | SHAMPOO / TOPICAL | NA | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 10 mg | ||
| Glycine | GLYCINE | TE7660XO1C | POWDER, FOR SOLUTION / ORAL | 0.09 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SOLUTION / ORAL | 1230 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| Glycine | GLYCINE | TE7660XO1C | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | CREAM / TOPICAL | 385 mg | ||
| Glycine | GLYCINE | TE7660XO1C | TABLET / ORAL | 163.31 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | POWDER, FOR SUSPENSION / ORAL | 1392 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 200 mg | ||
| Glycine | GLYCINE | TE7660XO1C | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | SOLUTION / TOPICAL | 0.3 %w/w | ||
| Glycine | GLYCINE | TE7660XO1C | CAPSULE, DELAYED RELEASE / ORAL | 50 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| Glycine | GLYCINE | TE7660XO1C | TABLET, ORALLY DISINTEGRATING / ORAL | 60 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Glycine | GLYCINE | TE7660XO1C | CAPSULE / ORAL | 62 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| Glycine | GLYCINE | TE7660XO1C | SOLUTION / ORAL | 50 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| Hexylene Glycol | HEXYLENE GLYCOL | KEH0A3F75J | GEL / TOPICAL | 280 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | 0.5 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / RECTAL | 452 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.5 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION / INTRAMUSCULAR | 68 mg | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / ORAL | 84 mg | ||
| Malic Acid | MALIC ACID | 817L1N4CKP | SOLUTION / ORAL | 16760 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| Butylene Glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 3.76 mg | ||
| Glycine | GLYCINE | TE7660XO1C | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 0.38 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg |
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 |
|---|---|---|---|---|---|---|
| 6e2ff42f-edbc-4526-9f86-33cdb8c93d1e | 912cbb41-de59-4062-9252-42b0a84f3aac | 2015-01-01 | Warnings | 6e2ff42f-edbc-4526-9f86-33cdb8c93d1e 912cbb41-de59-4062-9252-42b0a84f3aac |
Adverse event summaries are temporarily unavailable. Other product information remains available.