61312004

61312004
SPL v3
SPL
SPL Set ID 238ee30b-53fa-4f7b-895e-e440f79b989c
Route
TOPICAL
Published
Effective Date 2015-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Glycerin Propylene Glycol Dodecyl Propionate Polysorbate 20 Hexylene Glycol Benzyl Alcohol Sodium Lauraminopropionate Aloe Vera Leaf Tea Leaf Oil Chamomile Flower Oil Dmdm Hydantoin Phenoxyethanol Peg-40 Hydrogenated Lanolin Tocopheryl Retinoate Disodium Edta-copper Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-02-25

Description

salicylic acid 0.5%

Purpose

acne treatment


Medication Information

Purpose

acne treatment

Description

salicylic acid 0.5%

Use

for the treatment of acne

Section 51727-6

aqua (water),glycerin, propylene glycol , dodecyl polyglucoside, polysorbate 20,HEXYLENE GLYCOL , BENZYL ALCOHOL ,SODIUM LAURAMINOPROPIONATE ,ALOE BARBADENSIS(ALOE VERA )EXTRACT ,WHITE TEA EXTRACT ,CHAMOMILLA RECUTITA(CHAMOMILE)EXTRACT ,GLYDANT DMDM H,PHENOXYETHANOL ,PEG-40 HYDROGENATED CASTOR OIL,TOCOPHERYL ACETATE(VITAMIN E) ,DISODIUM EDTA,IODOPROPYNYL BUTYLCARBAMATE

Section 51945-4

Warnings

for external use only

when using this product

with other topical acne medications ,at the same time or immediately afterwards ,increased skin dryness ,redness or

irritation may occur .If this happens ,only one medication should be used unless directed by a doctor.

avoid contact with eyes .if contact occurs, rinse thoroughly with water. keep away from mouth and lips.

stop use and ask doctor if skin irritation occurs.

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

Directions

cleanse skin thoroughly before applying medication ,remove wipe ,unfold and wipe over entire affected area.

reseal label on package to maintain freshness.

Active Ingredient

salicylic acid 0.5%

Keep Out of Reach of Children

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


Structured Label Content

Use

for the treatment of acne

Section 51727-6 (51727-6)

aqua (water),glycerin, propylene glycol , dodecyl polyglucoside, polysorbate 20,HEXYLENE GLYCOL , BENZYL ALCOHOL ,SODIUM LAURAMINOPROPIONATE ,ALOE BARBADENSIS(ALOE VERA )EXTRACT ,WHITE TEA EXTRACT ,CHAMOMILLA RECUTITA(CHAMOMILE)EXTRACT ,GLYDANT DMDM H,PHENOXYETHANOL ,PEG-40 HYDROGENATED CASTOR OIL,TOCOPHERYL ACETATE(VITAMIN E) ,DISODIUM EDTA,IODOPROPYNYL BUTYLCARBAMATE

Section 51945-4 (51945-4)

Purpose

acne treatment

Warnings

for external use only

when using this product

with other topical acne medications ,at the same time or immediately afterwards ,increased skin dryness ,redness or

irritation may occur .If this happens ,only one medication should be used unless directed by a doctor.

avoid contact with eyes .if contact occurs, rinse thoroughly with water. keep away from mouth and lips.

stop use and ask doctor if skin irritation occurs.

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

Directions

cleanse skin thoroughly before applying medication ,remove wipe ,unfold and wipe over entire affected area.

reseal label on package to maintain freshness.

Active Ingredient (Active ingredient)

salicylic acid 0.5%

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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