Dosage and administration
APPLY GENEROUSLY TO AFFECTED AREAS, ESPECIALLY AFTER BATHING.
APPLY GENEROUSLY TO AFFECTED AREAS, ESPECIALLY AFTER BATHING.
ACTIVE INGREDIENT
COLLOIDAL OATMEAL
PURPOSE
SKIN PROTECTANT
TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATIONS AND ITCHING DUE TO ECZEMA, RASH AND DERMATITIS.
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES.
STOP USE AND ASK A DOCTOR IF
KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
APPLY GENEROUSLY TO AFFECTED AREAS, ESPECIALLY AFTER BATHING.
STORE AT 65-80°f. MAY STAIN FABRICS. FOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER.
ALLANTOIN, BEESWAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCINE SOYA (SOYBEAN) OIL, PARAFFIN WAX, PETROLATUM, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, TOCOPHEROL, ZINC OXIDE.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61328-901-93 | 2020-11-20 | C162847 | 48780-1 | 9d75b9d0-ca78-f424-e053-dadaa90a57ce | 602acd9c-b163-4ebb-ad24-43dfcb3d9769 |
| 61328-901-93 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ca78-f424-e053-dadaa90a57ce | 602acd9c-b163-4ebb-ad24-43dfcb3d9769 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OATMEAL | ACTIVE INGREDIENT | 8PI54V663Y | 3 | |
| OATMEAL | ACTIVE MOIETY | 8PI54V663Y | 3 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 3 | |
| ALMOND OIL | INACTIVE INGREDIENT | 66YXD4DKO9 | 3 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 3 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| APRICOT KERNEL OIL | INACTIVE INGREDIENT | 54JB35T06A | 3 | |
| CALENDULA OFFICINALIS FLOWER | INACTIVE INGREDIENT | P0M7O4Y7YD | 3 | |
| CAPRYLYL CAPRYLATE/CAPRATE | INACTIVE INGREDIENT | 22MCG4RSMR | 3 | |
| CETEARYL OLIVATE | INACTIVE INGREDIENT | 58B69Q84JO | 3 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 3 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 3 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| GLYCERYL STEARATE SE | INACTIVE INGREDIENT | FCZ5MH785I | 3 | |
| HELIANTHUS ANNUUS WHOLE | INACTIVE INGREDIENT | 17S27ZT6KR | 3 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 3 | |
| MATRICARIA RECUTITA FLOWERING TOP | INACTIVE INGREDIENT | 3VNC7T6Z02 | 3 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 3 | |
| OAT KERNEL OIL | INACTIVE INGREDIENT | 3UVP41R77R | 3 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | 3 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 3 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 3 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 3 | |
| RICE BRAN | INACTIVE INGREDIENT | R60QEP13IC | 3 | |
| ROSEMARY | INACTIVE INGREDIENT | IJ67X351P9 | 3 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 3 | |
| SORBITAN OLIVATE | INACTIVE INGREDIENT | MDL271E3GR | 3 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | 3 | |
| SUNFLOWER OIL | INACTIVE INGREDIENT | 3W1JG795YI | 3 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| TRISODIUM ETHYLENEDIAMINE DISUCCINATE | INACTIVE INGREDIENT | YA22H34H9Q | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 3 | |
| ZINC OXIDE | INACTIVE INGREDIENT | SOI2LOH54Z | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61328-901 | 61328-901-93 |
| 61328-109 | |
| 61328-102 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | OIL / TOPICAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LOTION / TOPICAL | 211 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION / ORAL | 1000 mg/15ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| GLYCERYL STEARATE SE | GLYCERYL STEARATE SE | FCZ5MH785I | LOTION / TOPICAL | 46 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | AEROSOL, FOAM / TOPICAL | 14235 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, COATED / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RECTAL | 904 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LOTION / TOPICAL | 25 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | CAPSULE, LIQUID FILLED / ORAL | NA | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | CAPSULE, EXTENDED RELEASE / ORAL | 80.67 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | FILM, SOLUBLE / ORAL | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / ORAL | 15 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| SOYBEAN OIL | SOYBEAN OIL | 241ATL177A | AEROSOL, FOAM / TOPICAL | 50 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER / ORAL | 275 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| PARAFFIN | PARAFFIN | I9O0E3H2ZE | OINTMENT / TOPICAL | 2860 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 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 |
|---|---|---|---|---|---|---|
| 9bf8c6fa-a72b-41c4-aa43-92a267d533f8 | 602acd9c-b163-4ebb-ad24-43dfcb3d9769 | 2020-11-20 | Warnings | 602acd9c-b163-4ebb-ad24-43dfcb3d9769 |
Adverse event summaries are temporarily unavailable. Other product information remains available.