Body Scrub

Product NDC
61671-003
11-digit product format
616710003
Labeler code
61671
Product ID
61671-003_de7705b6-2bbd-430f-85f1-b82ac4d319dd
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin and Kaolin
Dosage form
GEL
Route
TOPICAL
Labeler
Milk & Co Pty Ltd
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-08
Marketing end
0000-00-00
Substance
GLYCERIN; KAOLIN
Active strength
8 g/375g; g/375g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61671-003IInactivated by FDA2026-07-31
excluded packagepackage61671-00361671-003-01IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
BURTS BEES BABY BEE DIAPER RASHZINC OXIDEBURT'S BEES, INC.168b31b1-9260-61f8-e054-00144ff8d46c2018-12-21WarningsExact identifier
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
BALMEX ADULT CARE RASHZINC OXIDERandob Labs,Ltd.9443a987-c7b2-4b0d-a9dc-02233135af812018-11-13WarningsExact identifier
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
CVS Health Diaper RashZINC OXIDECVS Health12f786a0-0960-4b98-9f0b-dcf3725a98662017-03-20WarningsExact identifier
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61671-003-012019-11-27C16284748780-19855e2a2-5046-60a7-e053-dbdaa90a05bdd4a8bd8d-76db-4034-8fb0-b401522ee92a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61671-003-01Body Scrub375 g in 1 PACKAGEGEL3751

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
KAOLINACTIVE INGREDIENT24H4NWX5COBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
GLYCERINACTIVE MOIETYPDC6A3C0OXBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
KAOLINACTIVE MOIETY24H4NWX5COBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0BODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7BODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EPBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
JUGLANS REGIA SHELLINACTIVE INGREDIENTPJ10MT7VKABODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFABODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
PORPHYRA UMBILICALISINACTIVE INGREDIENT14AN0J70WOBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0BODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
SPIRULINA MAXIMAINACTIVE INGREDIENT9K7IG15M0QBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RBODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61671-003BODY SCRUB (GLYCERIN AND KAOLIN) GEL [MILK & CO PTY LTD]1Legacy NDC, 1 package rows20140109_d4a8bd8d-76db-4034-8fb0-b401522ee92a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
61671-003-0161671000301375 g in 1 PACKAGE375 gHistorical