Otc - Active Ingredient
Salicylic Acid (0.5%)
Tome Clearing Treatment Kit
FDA Label NDC 87609-104
10 label sections · Submitted to the FDA by Dermata Therapeutics, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermata Therapeutics, Inc. for the product Tome Clearing Treatment (NDC 87609-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - when using, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne Treatment
Warnings
For external use only.If you see signs of extreme redness, stinging, or excessive peeling, wait until your skin recovers to use the product.
When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.
If irritation occurs, only use one topical acne medication at a time.
Otc - When Using
• Do not get into eyes. If contact occurs, flush thoroughly with
water.
• Do not leave wipe on the skin for an extended period of time.
• If excessive irritation develops or increases, discontinue use and
consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
• Cleanse the skin thoroughly before using this product.
• Cover the affected area once weekly.
• Do not rinse.
• If bothersome dryness or peeling occurs,
reduce the application frequency.
Storage And Handling
Store at room temperature
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Caprylyl
Glycol, Citric Acid, Disodium EDTA,
Hamamelis Virginiana (Witch Hazel)
Bark/Leaf/Twig Extract, Lauryl Glucoside,
Menthol, Phenoxyethanol, PPG-5-Ceteth-20,
Sodium Hydroxide, Sodium Lauryl Glucose
Carboxylate, Water
Indications & Usage
• For the treatment of acne
• Reduces the number of acne blemishes and allows skin to heal
• Helps prevent the development of new acne blemishes
Package Label.Principal Display Panel
Clearing Treatment
Once-weekly for acne
TOME
Acne Clearing Treatment
0.5% Salicylic Acid Wipe + Bioneedle™ Mask
• 4 Salicylic Acid Acne Treatment Wipes 0.52 oz (14.7 g)
• 4 Bioneedle™ Cups 0.16 oz (4.4 g)
• 4 Activator Tubes 0.4 f l oz (12 mL)
Natural clearing treatment for acne
Developed to deeply treat the root causes of acne by clearing blemishes, preventing new breakouts,
and reducing the appearance of acne scars
Tome is studied
skincare.
Powered by Bioneedle™
Fast acting and powerful enough to be used once-weekly
Each once-weekly treatment includes: Wipe - Bioneedle™ – Activator – Brush
This box contains 4 weekly treatments,
to be refilled every 4 weeks
Bioneedle Ingredients:
Spongilla lacustrispowder
Activator Ingredients:
Water, Hydrogen Peroxide
For more information about the product and usage instructions, please see product packaging and brochure
Questions?
Visit www.tomeskincare.com
or call 1-800-563-7902
Distributed By:
Dermata Therapeutics, Inc.
Rancho Santa Fe, CA 92067
Made in the U.S.A with globally sourced components
Keep for refills
Dermatologically tested
Wipe
Salicylic Acid 0.5%
Acne Treatment
TOME 1 Wipe
* Please review the disclaimer below.
