First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry
First Aid Beauty FAB Ultra Repair Cream Skin Protectant Vanilla Cinnamon
Approved
Approval ID
30b2744d-fb59-f383-e063-6294a90abd2a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 19, 2025
Manufacturers
FDA
The Procter & Gamble Manufacturing Company
DUNS: 004238200
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Colloidal Oatmeal
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84126-105
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal Oatmeal
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 19, 2025
FDA Product Classification
INGREDIENTS (28)
SQUALANEInactive
Code: GW89575KF9
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
METHYL THIOBUTYRATEInactive
Code: 2P1E432MYZ
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
3-HEXEN-1-OL, FORMATE, (Z)-Inactive
Code: E34OB83TYM
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
TETRASODIUM EDTAInactive
Code: MP1J8420LU
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
OATMEALActive
Quantity: 0.5 g in 100 g
Code: 8PI54V663Y
Classification: ACTIB
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
BEACH STRAWBERRYInactive
Code: 98542F2TQS
Classification: IACT
AMAROLIDEInactive
Code: R289636IZ6
Classification: IACT
ETHYL 2-METHYLBUTYRATEInactive
Code: L1T4AB29DS
Classification: IACT
METHYL PHENYLACETATEInactive
Code: D4PDC41X96
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT