TIEGE HANLEY- salicylic acid cream

Tiege Hanley by

Drug Labeling and Warnings

Tiege Hanley by is a Otc medication manufactured, distributed, or labeled by Tiege Hanley. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Salicylic Acid 2%

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.

PURPOSE

Acne Treatment

DOSAGE & ADMINISTRATION

Directions
■ clean the skin
thoroughly before applying this
product
■ dispense 2-3 pumps of
Acne Serum into your palm and
emulsify before applying to your face
■cover the entire affected area
with a thin layer of product
■ apply once a day, morning or night

INDICATIONS & USAGE

Uses ■ For the management of acne

WARNINGS

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.
Do not use if you ■ have very
sensitive skin ■ are sensitive to
salicylic acid
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

INACTIVE INGREDIENT

Inactive Ingredients:
Water/Aqua/Eau, Helianthus Annuus
(Sunflower) Seed Oil, Glyceryl Stearate
SE, Cetyl Alcohol, Butylene Glycol,
Glycerin, Squalane, Sodium Acrylates
Copolymer, Phenoxyethanol, Jojoba
Oil/Macadamia Seed Oil Esters,
Cetearyl Olivate, Sorbitan Olivate,
Hydrolyzed Jojoba Esters, Lecithin,
Xanthan Gum, Sodium Benzoate,
Squalene, Ethylhexylglycerin, Potassium
Sorbate, Propanediol, Panthenol,
Melaleuca Alternifolia (Tea Tree) Leaf
Oil, Phytosteryl Macadamiate, Avena
Sativa (Oat) Bran Extract, Tocopheryl
Acetate, Phytosterols, Boswellia Serrata
Extract, Honey Extract (Mel Extract),
Oryza Sativa (Rice) Bran Extract,
Tocopherol, Maltodextrin, Niacinamide,
Pantolactone, Aloe Barbadensis Leaf
Juice, Oligopeptide-10, Aminomethyl
Propanol, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIEGE HANLEY 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71714-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
JOJOBA OIL (UNII: 724GKU717M)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
SORBITAN OLIVATE (UNII: MDL271E3GR)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
PANTOLACTONE (UNII: J288D7O0JS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F)
PANTHENOL (UNII: WV9CM0O67Z)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
XANTHAN GUM (UNII: TTV12P4NEE)
NIACINAMIDE (UNII: 25X51I8RD4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SQUALANE (UNII: GW89575KF9)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHERYLOXYACETIC ACID (UNII: JW7FJR3ZLY)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
HONEY (UNII: Y9H1V576FH)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SQUALENE (UNII: 7QWM220FJH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71714-003-24	24 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/01/2024

Labeler - Tiege Hanley (080305325)

Registrant - Tiege Hanley (080305325)