Label: TRIDERMA STUBBORN DIAPER RASH RELIEF- allantoin, dimethicone cream
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NDC Code(s):
10738-068-20,
10738-068-25,
10738-068-40,
10738-068-45, view more10738-068-50, 10738-068-55
- Packager: Genuine Virgin Aloe Corporation
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 2, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Drug Facts
- Active ingredients
- Purpose
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: water, butyrospermum parkii (shea) butter, glycerin, glyceryl stearate SE, cera alba (beeswax), cetearyl alcohol, carthamus tinctorius (safflower) seed oil, avena sativa (oat) kernel flour, polysorbate 60, polysorbate 80, cetyl esters, zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), tocopheryl acetate (vitamin E), glyceryl stearate, sorbic acid, sodium hyaluronate, sodium phytate, sodium hydroxide, cetyl potassium phosphate, xanthan gum, phenoxyethanol, ethylhexylglycerin. *Certified Organic Ingredient - Mayacert Certifier
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SPL UNCLASSIFIED SECTION
Helps treat & prevent diaper rash
Helps seal out wetness
Dermatologist Tested
This maximum strength cream works quickly to help relieve everyday or hard-to-heal, stubborn diaper rash.
Stubborn diaper rash can be result of changes in diet, medication, or prolonged wetness.
Made with essential botanicals, vitamins, AP4 ® Organic Aloe * Complex and clinically proven skin protectants, this soothing cream helps promote healing after the 1st use.
AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend
Colloidal Oats - helps soothe & relieve irritated skin
Shea Butter - soothes & moisturizes
Beeswax - calming properties
Zinc PCA - additional healing
Also try:
Stubborn Eczema Itch™ Relief Cream
Aloe Healing & Cleansing Gel™
Daily Calming™ Moisturizer
Maximum Strength
Healing BotanicalsStubborn Diaper Rash™ Relief Cream contains more healing power and is less sticky/gooey than most traditional diaper rash creams.
• Works quickly
• Soothes tender skin
• Helps prevent diaper rash from recurringNon-Greasy • No Added Fragrance
Free from Cortisone, Steroids & ParabensEXPERTS IN SKIN HEALING SINCE 1992
TriDerma MD ® provides healing solutions for irritated skin without harmful side effects.
It all began after one woman struggled to find safe and effective healing for her own skin problem.
This journey led to the creation of our proprietary AP4 ® Organic Aloe* Complex which is key to all our products.
QUALITY YOU CAN FEEL, RESULTS YOU CAN SEE. ®
Each product is made using this powerful complex plus nature’s best botanicals and clinically proven ingredients.
We are passionate in our pursuit to create fast healing products that work.
Learn More at www.triderma.com
MADE IN THE USA
Dist. by: Genuine Virgin Aloe Corp., Corona, CA 92879 ©2019 0919
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INGREDIENTS AND APPEARANCE
TRIDERMA STUBBORN DIAPER RASH RELIEF
allantoin, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10738-068 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 1.5 g in 100 g DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHEA BUTTER (UNII: K49155WL9Y) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) WHITE WAX (UNII: 7G1J5DA97F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SAFFLOWER OIL (UNII: 65UEH262IS) OATMEAL (UNII: 8PI54V663Y) POLYSORBATE 60 (UNII: CAL22UVI4M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CETYL ESTERS WAX (UNII: D072FFP9GU) ZINC PIDOLATE (UNII: C32PQ86DH4) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALOE VERA LEAF (UNII: ZY81Z83H0X) DEXPANTHENOL (UNII: 1O6C93RI7Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBIC ACID (UNII: X045WJ989B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM PHOSPHATE, TRIBASIC (UNII: 16D59922JU) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10738-068-50 1 in 1 CARTON 10/31/2019 1 NDC:10738-068-55 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10738-068-20 1 in 1 CARTON 10/31/2019 2 NDC:10738-068-25 62 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10738-068-40 1 in 1 CARTON 10/31/2019 3 NDC:10738-068-45 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 10/31/2019 Labeler - Genuine Virgin Aloe Corporation (961374147) Establishment Name Address ID/FEI Business Operations Genuine Virgin Aloe Corporation 961374147 manufacture(10738-068)