ZITLOX SALICYLIC ACNE- salicylic acid gel

Zitlox Salicylic Acne by

Drug Labeling and Warnings

Zitlox Salicylic Acne by is a Otc medication manufactured, distributed, or labeled by ASA Universal Inc. dba: SONAGE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic Acid 1.5%

Purpose

Acne Treatment

Uses

• clears acne blemishes and allows skin to heal
• helps prevent new acne blemishes from forming

Warnings

For external use only

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

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 time 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 doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

bacillus ferment filtrate extract (postbiotic), benzyl alcohol, carthamnus tinctorius (safflower) oil, cocos nucifera (coconut) oil, dehydroacetic acid, diatomaceous earth, eucalyptus globulus leaf oil, glycerin, helianthus annuus (sunflower) seed oil, melaleuca alternifolia (tea tree) leaf oil, melia azadirachta (neem) seed oil, mentha piperita (peppermint) oil, olea europaea (olive) fruit oil, polyacrylate crosspolymer-6, sodium hydroxide, t-butyl alcohol, water, xanthan gum

Principal Display Panel

SONÄGE®

ZITLOX
SALICYLIC
ACNE GEL
 
CLEARS ACNE
BLEMISHES

Dermatologist Tested
Clinically Tested

 

POSTBIOTIC
TEA TREE
EUCALYPTUS

15 ml. / 0.5 fl. oz.
THE NEW NATURAL®

 

Dist. by/par Sonäge, Santa Monica,
CA 90405 U.S.A
sonage.com

Label

INGREDIENTS AND APPEARANCE

ZITLOX SALICYLIC ACNE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69546-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
SAFFLOWER OIL (UNII: 65UEH262IS)
COCONUT OIL (UNII: Q9L0O73W7L)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)
PEPPERMINT OIL (UNII: AV092KU4JH)
OLIVE OIL (UNII: 6UYK2W1W1E)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69546-201-02	1 in 1 CARTON	06/30/2022
1		15 mL in 1 BOTTLE, PUMP; 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	06/30/2022

Labeler - ASA Universal Inc. dba: SONAGE (054687895)