NDC 61328-116

12 Hour Healing

Allantoin

12 Hour Healing is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Skinfix, Inc.. The primary component is Allantoin.

Product ID61328-116_cc35868f-2f0b-4832-a936-479f4cc19da8
NDC61328-116
Product TypeHuman Otc Drug
Proprietary Name12 Hour Healing
Generic NameAllantoin
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2017-05-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameSkinfix, Inc.
Substance NameALLANTOIN
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61328-116-11

102 g in 1 TUBE (61328-116-11)
Marketing Start Date2017-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61328-116-11 [61328011611]

12 Hour Healing OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-02
Marketing End Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
ALLANTOIN.5 g/100g

OpenFDA Data

SPL SET ID:deb8ebdc-756a-48e0-8f04-0ac1f6ca6316
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044541
  • NDC Crossover Matching brand name "12 Hour Healing" or generic name "Allantoin"

    NDCBrand NameGeneric Name
    61328-11612 Hour Healing12 Hour Healing
    52342-001Anti Chafe BalmAllantoin
    44019-400Baby Wipes with AllantoinALLANTOIN
    44781-130BIOWHITE BEAUTY SERUMALLANTOIN
    42021-036Body ArmorAllantoin
    15197-007Bodyglide anti chafe balmAllantoin
    15197-009Bodyglide For HerAllantoin
    51483-002Burn-B Gone OTCAllantoin
    0299-4103Cetaphil Baby Soothe and Protect Creamallantoin
    0299-4105Cetaphil Soothing Gel Creamallantoin
    15197-008Chamois GlideAllantoin
    11084-042Cool MelonAllantoin
    10738-301DIABETIC BRUISE DEFENSEALLANTOIN
    43948-5001Dr Young 2p Blemish Base SPF35 PAALLANTOIN
    52891-103DR. OBERON NATURAL BABYallantoin
    43948-1101Dr. Young 2P Pearl Brightening Balm SPF35 PAALLANTOIN
    49035-838Equate ScarAllantoin
    42387-300Grahams Natural Eczema Gelallantoin
    51270-116Hasol Revitalizing Scalp AmpouleALLANTOIN
    45156-5616Inflammation OTCAllantoin
    51985-010IONTOPHORESISALLANTOIN
    0259-1105Mederma Advanced ScarAllantoin
    0259-1101Mederma for KidsAllantoin
    51346-218ORIGINAL POWER REFIRMING AMPOULEAllantoin
    51346-219ORIGINAL POWER WHITENING AND LINELESS AMPOULEALLANTOIN
    52123-050PURE RED RED GINSENG CLEANSINGAllantoin
    24474-001Run Guard OriginalALLANTOIN
    24474-002Run Guard SensitiveALLANTOIN
    52319-001Sarene Soothing SkinAllantoin
    11084-040SBS 40Allantoin
    11084-240SBS 40Allantoin
    11084-241SBS 40 Medicated CreamAllantoin
    11084-141SBS 41 Medicated CreamAllantoin
    11084-089SBS CareAllantoin
    49967-783SkinCeuticals Advanced Scar Control Skin ProtectantAllantoin
    50795-2001U-max Multi BBALLANTOIN
    50795-3001U-max Whitening Functional EssenceALLANTOIN
    11673-700Up and Up Advanced ScarALLANTOIN
    54111-113YES to coconutALLANTOIN

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