KLENSKIN KIDS SHOWERON SUNSCREEN
- Manufacturer
- CoLabs Intl. Corp
- Effective date
- 2024-01-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- full-release
- Hydrated at
- 2026-06-01 00:07:14
Label at a glance#
ProductKLENSKIN KIDS SHOWERON SUNSCREEN SPF-30
Active ingredientAVOBENZONE, OCTOCRYLENE, OCTINOXATE
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS
AVOBENZONE 2.75%
OCTOCRYLENE 7.04%
OCTINOXATE 7.2%
OTC - PURPOSE SECTION
PURPOSE
SUNSCREEN
INDICATIONS & USAGE SECTION
USES
- HELPS PREVENT SUNBURN
- IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.
WARNINGS SECTION
WARNINGS
- FOR EXTERNAL USE ONLY
- DO NOT USE ON DAMAGED OR BROKEN SKIN.
- WHEN USING THIS PRODUCT, KEEP OUT OF EYES AND RINSE WITH EXCESSIVE WATER TO REMOVE.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
OTC - STOP USE SECTION
STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
- SHAKE WELL BEFORE USE
- APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE
- REAPPLY:
- AFTER 80 MINUTES OF SWIMMING, SWEATING OR EXPOSURE TO WATER
- IMMEDIATELY AFTER TOWEL DRYING
- AT LEAST EVERY 2 HOURS
OTHER SAFETY INFORMATION
SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
- LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
OTHER INFORMATION
- PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS
WATER, DISODIUM LAURETH SULFOSUCCINATE, COCAMIDOPROPYL BETAINE, SODIUM COCOYL ISETHIONATE, SODIUM METHYL COCOYL TAURATE, POLYSORBATE 20, PEG-150 PENTAERYTHRITYL TETRASTEARATE, GLYCERIN, SORBITAN MONOOLEATE, COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN, BUTYROSPERMUM PARKII (SHEA) OIL, DIMETHICONE, POLYAMIDE-3, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, SORBITAN STEARATE, CARBOXYMETHYCELLULOSE NA, ETHYLENEDIAMNE/STEARYL DIMER DILINOLEATE COPOLYMER, PG HYDROXYETHYLCELLULOSE STEARYLDIMONIUM CHLORIDE, SODIUM LAURYL GLUCOSE CARBOXYLATE, POLYQUATERNIUM 10, PHENOXYETHANOL, FRAGRANCE, CAPRYLYL GLYCOL, TETRASODIUM EDTA, LAURDIMONIUMHYDROXYPROPYL DECYLGLUCOSIDES CHLORIDE, LAURYL GLUCOSIDE, GELLAN GUM, SODIUM ALGINATE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ARCTIUM LAPPA (BURDOCK ROOT) EXTRACT, CAMELIA OLEIFERA (GREEN TEA) SEED OIL, PUNICA GRANATUM (POMEGRANATE) SEED OIL, RUBEUS IDAEUS (RED RASPBERRY) OIL, VACCINIUM MACROCARPON (CRANBERRY) SEED OIL, CARRAGEENAN, CITRIC ACID, SODIUM CHLORIDE
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS? PLEASE CALL TOLL FREE 888.878.5536
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61369-102-18 | KLENSKIN KIDS SHOWERON SUNSCREENSPF-30 | 236 mL in 1 BOTTLE | GEL | 236 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 5 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 5 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 5 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 5 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 5 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 5 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 5 | |
| ARCTIUM LAPPA ROOT | INACTIVE INGREDIENT | 597E9BI3Z3 | 5 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 5 | |
| CARBOMER COPOLYMER TYPE A | INACTIVE INGREDIENT | 71DD5V995L | 5 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 5 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | 5 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 5 | |
| CRANBERRY SEED OIL | INACTIVE INGREDIENT | 73KDS3BW5E | 5 | |
| DECYL GLUCOSIDE | INACTIVE INGREDIENT | Z17H97EA6Y | 5 | |
| DIISOSTEARYL DIMER DILINOLEATE | INACTIVE INGREDIENT | 04P17590AP | 5 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 5 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 5 | |
| ETHYLENEDIAMINE | INACTIVE INGREDIENT | 60V9STC53F | 5 | |
| GELLAN GUM (LOW ACYL) | INACTIVE INGREDIENT | 7593U09I4D | 5 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 5 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 5 | |
| HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) | INACTIVE INGREDIENT | ZR28QKN0WT | 5 | |
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | INACTIVE INGREDIENT | 8136Y38GY5 | 5 | |
| LAURYL GLUCOSIDE | INACTIVE INGREDIENT | 76LN7P7UCU | 5 | |
| LAURYL SULFOSUCCINATE | INACTIVE INGREDIENT | L81TQ3126P | 5 | |
| PEG-150 PENTAERYTHRITYL TETRASTEARATE | INACTIVE INGREDIENT | 8L4OOQ76AM | 5 | |
| PEG-6 CAPRYLIC/CAPRIC GLYCERIDES | INACTIVE INGREDIENT | GO50W2HWO8 | 5 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 5 | |
| POLYACRYLAMIDE (1500 MW) | INACTIVE INGREDIENT | 5D6TC4BRWV | 5 | |
| POLYQUATERNIUM-10 (1000 MPA.S AT 2%) | INACTIVE INGREDIENT | GMR4PEN8PK | 5 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 5 | |
| POMEGRANATE | INACTIVE INGREDIENT | 56687D1Z4D | 5 | |
| RASPBERRY SEED OIL | INACTIVE INGREDIENT | 9S8867952A | 5 | |
| SHEANUT OIL | INACTIVE INGREDIENT | O88E196QRF | 5 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| SODIUM COCOYL ISETHIONATE | INACTIVE INGREDIENT | 518XTE8493 | 5 | |
| SODIUM LAURYL GLYCOL CARBOXYLATE | INACTIVE INGREDIENT | 8L0472VMYL | 5 | |
| SODIUM METHYL COCOYL TAURATE | INACTIVE INGREDIENT | JVL98CG53G | 5 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | 5 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Products#
Every source-derived product name is available through these pages.
- KLENSKIN KIDS SHOWERON SUNSCREEN SPF-30
- AVOBENZONE, OCTOCRYLENE, OCTINOXATE
- WATER
- LAURYL SULFOSUCCINATE
- COCAMIDOPROPYL BETAINE
- SODIUM COCOYL ISETHIONATE
- SODIUM METHYL COCOYL TAURATE
- POLYSORBATE 20
- PEG-150 PENTAERYTHRITYL TETRASTEARATE
- GLYCERIN
- SORBITAN MONOOLEATE
- HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)
- SHEANUT OIL
- DIMETHICONE
- POLYACRYLAMIDE (1500 MW)
- PEG-6 CAPRYLIC/CAPRIC GLYCERIDES
- SORBITAN MONOSTEARATE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- ETHYLENEDIAMINE
- DIISOSTEARYL DIMER DILINOLEATE
- HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)
- SODIUM LAURYL GLYCOL CARBOXYLATE
- POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
- EDETATE SODIUM
- DECYL GLUCOSIDE
- LAURYL GLUCOSIDE
- GELLAN GUM (LOW ACYL)
- SODIUM ALGINATE
- CARBOMER COPOLYMER TYPE A
- ARCTIUM LAPPA ROOT
- GREEN TEA LEAF
- POMEGRANATE
- RASPBERRY SEED OIL
- CRANBERRY SEED OIL
- CARRAGEENAN
- ANHYDROUS CITRIC ACID
- SODIUM CHLORIDE
- AVOBENZONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61369-102 | 61369-102-18 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRAVENOUS | 1152 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | IMPLANT / SUBCUTANEOUS | 77 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / NASAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / NASAL | 7.4 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVESICAL | 351 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / OPHTHALMIC | 0.09 %w/v | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUPPOSITORY / VAGINAL | NA | ||
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | CAPSULE / ORAL | 20 mg | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | PASTE / DENTAL | 0.3 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | LOTION / TOPICAL | 0.17 %w/w | ||
| SORBITAN MONOOLEATE | SORBITAN MONOOLEATE | 06XEA2VD56 | SUPPOSITORY / RECTAL | 390 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERINEURAL | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / SUBCUTANEOUS | 25 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / TOPICAL | 2.15 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / INTRACARDIAC | 25 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 11 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.86 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 25 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRASYNOVIAL | 4 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SOLUTION / ORAL | 161 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | OINTMENT / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / PARENTERAL | 210 mg | ||
| ETHYLENEDIAMINE | ETHYLENEDIAMINE | 60V9STC53F | CREAM / TOPICAL | 0.18 %w/w | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | CREAM / TOPICAL | 177 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAMUSCULAR | 26 mg | ||
| ETHYLENEDIAMINE | ETHYLENEDIAMINE | 60V9STC53F | INJECTION / INTRAVENOUS | 0.39 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVENOUS | 28773 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRALESIONAL | 0.9 %w/v | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SOLUTION / TOPICAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / ORAL | 1126 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| CARBOMER COPOLYMER TYPE A | CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) | 71DD5V995L | LOTION / TOPICAL | 21 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.68 %w/v | ||
| HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | SOLUTION / ORAL | 1867 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / ORAL | 3480 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| POLYSORBATE 20 | POLYSORBATE 20 | 7T1F30V5YH | SHAMPOO / TOPICAL | 8 %w/w | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | CAPSULE / ORAL | 3 mg |
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 |
|---|---|---|---|---|---|---|
| 0f03a8e5-d9b0-3134-e063-6294a90ae931 | 2e394662-dd0a-4d0d-b4b0-568ecf7e2555 | 2024-01-15 | Warnings | 0f03a8e5-d9b0-3134-e063-6294a90ae931 2e394662-dd0a-4d0d-b4b0-568ecf7e2555 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.