FDA.reportPublic FDA data

ProCure SkinGuard

Product NDC
55681-077
11-digit product format
556810077
Labeler code
55681
Product ID
55681-077_5cb4ae80-cf37-3b3d-e063-6294a90a54f1
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum and Zinc Oxide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Twin Med LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-29
Substance
ZINC OXIDE; PETROLATUM
Active strength
2; 49.9 g/100g; g/100g
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
ProCure SkinGuard
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE2 g/100g
PETROLATUM49.9 g/100g

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 55 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveMOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdebc5983-e8bc-c6d5-e053-2995a90af7742024-11-07WarningsExact identifier
application number: M016
Baby Dove8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREEConopco Inc. d/b/a/ Unileverdf734b51-33ae-d6b7-e053-2995a90a08cc2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENTConopco Inc. d/b/a/ Unileverdf73e518-caec-a73b-e053-2995a90a69f52024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER DEEP MOISTUREConopco Inc. d/b/a/ Unileverddca7c55-0a7e-cea6-e053-2995a90ace5a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER SHEA BUTTERConopco Inc. d/b/a/ Unileverddcad36b-1909-3bbb-e053-2995a90a295a2024-11-07WarningsExact identifier
application number: M016
DoveNOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATIONConopco Inc. d/b/a/ Unileverddcbab1c-7af9-2656-e053-2995a90ad07a2024-11-07WarningsExact identifier
application number: M016
DoveHAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENTConopco Inc. d/b/a/ Unileverdf74d901-c86c-ed71-e053-2995a90a39c22024-11-07WarningsExact identifier
application number: M016
Aveeno Baby Calming Comfort Bath Plus SetDIMETHICONEKenvue Brands LLC2c44fbc7-588f-41e2-953c-eebf24eecbf92024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
application number: M016
Avene XERACALM Eczema Calming Relief BalmCOLLOIDAL OATMEALPierre Fabre USA Inc.1315f006-0e96-2074-e063-6394a90a60372024-11-06WarningsExact identifier
application number: M016
Aveeno Baby Daily Moisture with Coconut Oil and Shea ButterDIMETHICONEKenvue Brands LLCeb71f8b1-bbcd-f338-e053-2995a90a80f12024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Daily MoisturizingCOLLOIDAL OATMEALKenvue Brands LLCe4c85780-7cb2-b55c-e053-2995a90a03142024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC62025bfa-245e-4369-9949-d31ea455ad312024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLCf2fd12cf-45c0-163f-e053-2a95a90ad4592024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC3d3da49e-dba6-4c6b-9278-5c8692e29f142024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Itch Relief BalmOATMEALKenvue Brands LLCbab3b767-864c-4c9f-b812-4fbd2bf2ca772024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLC1bad1069-b169-4bc9-8eb8-5123d57f74e52024-11-05WarningsExact identifier
application number: M016
Aveeno Skin Relief Moisturizing Fragrance FreeDIMETHICONEKenvue Brands LLCe0d9b055-be7a-8bba-e053-2995a90ab9e32024-11-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy daily moisturizingOATMEALKenvue Brands LLCdcbdb2ce-3877-41ea-9978-986e17a7c8772024-11-05WarningsExact identifier
application number: M016
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-077-1455681007714144 PACKET in 1 CARTON (55681-077-14) / 5 g in 1 PACKET (55681-077-05) 144 packet2026-09-30NoNoCurrent
55681-077-355568100773599.2 g in 1 TUBE (55681-077-35) 99.2 g2026-09-30NoNoCurrent