Soft Services CLEARING Mist Breakout Tonic: Package Insert and Label Information

SOFT SERVICES CLEARING MIST BREAKOUT TONIC- salicylic acid liquid
A TO Z INTERNATIONAL CORPORATION

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.

Active Ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• for the treatment of acne

Warnings

For external use only
Using other topical acne medications at the same time or immediately following use of this
product may increase dryness or irritation of the skin. If this occurs, only one medication should
be used unless directed by a doctor.

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.

Directions

• clean the skin thoroughly before applying this product • cover the entire
affected area with a thin layer one to three times daily • because excessive drying of the
skin may occur, start with one application daily, then gradually increase to two or three times
daily if needed or as directed by a doctor • if bothersome dryness or peeling occurs, reduce
application to once a day or every other day.

Inactive Ingredients

Water, Alcohol Deant., Aloe Barbadensis Leaf Juice, Niacinamide, Zinc PCA, Melaleuca Alternifolia Leaf Oil, Glycerin, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Smilax Aristolochiaefolia Root Extrac, Citric Acid

Questions or comments?

Email us at info@softservices.co or call us toll-free 1-844-959-0666

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SOFT SERVICES CLEARING MIST BREAKOUT TONIC
acne treatment liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:82030-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
ALOE VERA LEAF
NIACINAMIDE
ZINC
MELALEUCA ALTERNIFOLIA LEAF
GLYCERIN
ARCTIUM LAPPA ROOT
CALENDULA OFFICINALIS FLOWER
SMILAX ARISTOLOCHIIFOLIA ROOT
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:82030-010-04 1 TUBE in 1 CARTON contains a TUBE
1 4 g in 1 TUBE This package is contained within the CARTON (82030-010-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 06/30/2021
Labeler — A TO Z INTERNATIONAL CORPORATION (118126793)

Revised: 06/2021 A TO Z INTERNATIONAL CORPORATION

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