FDA.reportPublic FDA data

Critic Aid Clear

Product NDC
11701-066
11-digit product format
117010066
Labeler code
11701
Product ID
11701-066_5a52f10b-cf1f-4c6e-a662-505beb528d2a
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Coloplast Corp
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-06-15
Substance
PETROLATUM
Active strength
710 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Critic Aid Clear
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM710 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
686452Internal RxNorm lookup
1053000Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b6da97e-519b-4579-9895-f4ede5c48b47Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11701-066-222023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-322023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-332023-12-21Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-222023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-322023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment
11701-066-332023-01-30Critic-Aid ® Clear Skin Protectant Clear Moisture Barrier Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-066-22Critic Aid Clear4 g in 1 PACKETOINTMENT47
11701-066-32Critic Aid Clear170 g in 1 TUBEOINTMENT1707
11701-066-33Critic Aid Clear71 g in 1 TUBEOINTMENT717

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-066-22GM - Gram11701-06684478602-2e57-4d1d-a8c5-3ee34398424812012-07-24
11701-066-32GM - Gram11701-06622339e53-526e-4c45-9d06-56436883b76e12012-07-24
11701-066-33GM - Gram11701-066ee97a8dc-3c0b-4d46-9170-785a8cceee9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
PETROLATUMACTIVE MOIETY4T6H12BN9UCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZCRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-066CRITIC AID CLEAR (PETROLATUM) OINTMENT [COLOPLAST MANUFACTURING US, LLC]6Current NDC, Legacy NDC, 3 package rows20231222_0b6da97e-519b-4579-9895-f4ede5c48b47.zip

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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053000Critic-Aid Clear Moisture Barrier 71.5 % Topical OintmentPSN0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 71.5 % Topical OintmentPSN0b6da97e-519b-4579-9895-f4ede5c48b477
1053000petrolatum 0.715 MG/MG Topical Ointment [Critic-Aid Clear Moisture]SBD0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 0.715 MG/MG Topical OintmentSCD0b6da97e-519b-4579-9895-f4ede5c48b477
1053000Critic-Aid Clear Moisture 0.715 MG/MG Topical OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477
1053000Critic-Aid Clear Moisture Barrier 71.5 % OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477
686452petrolatum 71.5 % Topical OintmentSY0b6da97e-519b-4579-9895-f4ede5c48b477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-066-22117010066224 g in 1 PACKET (11701-066-22) 4 g2009-06-150000-00-00NoNoCurrent
11701-066-3211701006632170 g in 1 TUBE (11701-066-32) 170 g2009-06-150000-00-00NoNoCurrent
11701-066-331170100663371 g in 1 TUBE (11701-066-33) 71 g2009-06-150000-00-00NoNoCurrent