TRIDERMA ACNE SPOT TREATMENT- benzoyl peroxide cream

TRIDERMA Acne Spot Treatment by

Drug Labeling and Warnings

TRIDERMA Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Genuine Virgin Aloe Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5%

Purpose

Acne Treatment

INDICATIONS & USAGE

Uses for the treatment of acne clears acne blemishes helps prevent new blemishes from forming.

WARNINGS

Warnings For external use only.

When using this product avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips and mouth avoid contact with hair and dyed fabric, which may be bleached by the product skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. 

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 

DOSAGE & ADMINISTRATION

Directions clean the skin thoroughly before applying the product cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase 2 to 3 times daily if needed or directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and ask a doctor.

STORAGE AND HANDLING

Other information store at room temperature keep carton for important information.

INACTIVE INGREDIENT

Inactive ingredients: water, olive oil glycereth-8 esters, carbomer, aloe barbadensis leaf juice*, sodium hydroxide, phenoxyethanol. *Certified Organic Ingredient - Mayacert Certifier

QUESTIONS

Questions? 1-800-279-7282 M-F 8am-4pm PST or www.triderma.com

SPL UNCLASSIFIED SECTION

For Healthier Looking Skin

Clears acne

Helps prevent new blemishes from forming

Dermatologist Tested

AP4® BOTANICAL  ALOE VERA COMPLEX

Acne Spot Treatment works quickly to clear acne blemishes and help prevent new blemishes from forming.

Helps keep skin clear
Purifies pores
Pores look smaller

Made with acne fighting Benzoyl Peroxide, this powerful serum delivers results for a clear and healthy looking complexion.

AP4® Botanical Aloe Complex is a proprietary soothing botanical blend

Non-Greasy
No Added Fragrance or Parabens

EXPERTS 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.

MADE IN THE USA

Maximum Strength Healing Botanicals

Dist by: Genuine Virgin Aloe Corp. Corona,

CA 92879  ©2019 0819

packaging

INGREDIENTS AND APPEARANCE

TRIDERMA ACNE SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10738-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OLIVE OIL GLYCERETH-8 ESTERS (UNII: 322K2STO13)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10738-034-10	1 in 1 CARTON	12/30/2019
1	NDC: 10738-034-15	21 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	part333D	12/30/2019

Labeler - Genuine Virgin Aloe Corporation (961374147)

Establishment
Name	Address	ID/FEI	Business Operations
Genuine Virgin Aloe Corporation		961374147	manufacture(10738-034)