Label: TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF- colloidal oatmeal cream
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NDC Code(s):
10738-069-20,
10738-069-25,
10738-069-40,
10738-069-45, view more10738-069-50, 10738-069-55
- Packager: Genuine Aloe Virgin Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 31, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: water, cetearyl alcohol, urea, isopropyl palmitate, arnica montana flower extract, glycerin, polysorbate 60, cera alba (beeswax), dimethicone, allantoin,zinc PCA, sodium PCA, aloe barbadensis leaf juice*, panthenol (pro-vitamin B5), butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), sodium hyaluronate, cetyl alcohol, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.
*Certified Organic Ingredient - Mayacert Certifier
- QUESTIONS
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SPL UNCLASSIFIED SECTION
Helps relieve minor skin irritation & itching due to eczema & rashes
Dermatologist Tested
Colloidal Oatmeal
Skin Protectant
This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes.
It provides long-lasting moisture and powerful, yet gentle, itch relief.
Enriched with essential botanicals, AP4 ® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides
soothing relief for all ages.AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend
Colloidal Oats - helps soothe & relieve itching, rashes & eczema
Arnica Montana - known to help soothe irritated skin
Shea Butter - soothes & moisturizes
Vitamins, Beeswax, Allantoin & Zinc PCA
For healthier skin, also try:
Eczema Itch Relief Wash & ShampooHealing All Purpose Cream
Daily Calming™ Moisturizer
Maximum Strength
Healing BotanicalsStubborn Eczema Itch™ Relief Cream provides the special care needed to help protect sensitive skin against dryness, rashes and
eczema related symptoms that can appear anywhere on the body.- Works quickly
- Soothes, moisturizes & protects
- Powerful itch relief
Clinically Tested, Safe for Sensitive Skin
Non-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
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Packaging
Helps relieve minor skin irritation & itching due to eczema & rashes
Dermatologist Tested
Colloidal Oatmeal
Skin Protectant
This concentrated botanical cream helps relieve extra dry, red or irritated skin due to eczema and rashes.
It provides long-lasting moisture and powerful, yet gentle, itch relief.
Enriched with essential botanicals, AP4 ® Organic Aloe* Complex and clinically proven Colloidal Oats, it provides
soothing relief for all ages.AP4 ® Organic Aloe* Complex - proprietary soothing botanical blend
Colloidal Oats - helps soothe & relieve itching, rashes & eczema
Arnica Montana - known to help soothe irritated skin
Shea Butter - soothes & moisturizes
Vitamins, Beeswax, Allantoin & Zinc PCA
For healthier skin, also try:
Eczema Itch Relief Wash & ShampooHealing All Purpose Cream
Daily Calming™ Moisturizer
Maximum Strength
Healing BotanicalsStubborn Eczema Itch™ Relief Cream provides the special care needed to help protect sensitive skin against dryness, rashes and
eczema related symptoms that can appear anywhere on the body.Works quickly
Soothes, moisturizes & protects
Powerful itch reliefClinically Tested, Safe for Sensitive Skin
Non-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
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INGREDIENTS AND APPEARANCE
TRIDERMA BABY STUBBORN ECZEMA ITCH RELIEF
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10738-069 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) UREA (UNII: 8W8T17847W) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 60 (UNII: CAL22UVI4M) YELLOW WAX (UNII: 2ZA36H0S2V) DIMETHICONE (UNII: 92RU3N3Y1O) ALLANTOIN (UNII: 344S277G0Z) ZINC PIDOLATE (UNII: C32PQ86DH4) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) SHEA BUTTER (UNII: K49155WL9Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CETYL ALCOHOL (UNII: 936JST6JCN) PHYTATE SODIUM (UNII: 88496G1ERL) SODIUM HYDROXIDE (UNII: 55X04QC32I) 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:10738-069-40 1 in 1 CARTON 08/30/2019 1 NDC:10738-069-45 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10738-069-20 1 in 1 CARTON 08/30/2019 2 NDC:10738-069-25 62 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10738-069-50 1 in 1 CARTON 08/30/2019 3 NDC:10738-069-55 14 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 08/30/2019 Labeler - Genuine Aloe Virgin Corporation (961374147) Establishment Name Address ID/FEI Business Operations Genuine Aloe Virgin Corporation 961374147 manufacture(10738-069)