Salicylic Acid by Alps South, LLC / Alps South LLC

Salicylic Acid by

Drug Labeling and Warnings

Salicylic Acid by is a Otc medication manufactured, distributed, or labeled by Alps South, LLC, Alps South LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SALICYLIC ACID- salicylic acid cream 
Alps South, LLC

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.

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Active Ingredient(s)

Salicylic Acid .5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.

Do not apply over open wounds or infection.

Avoid contact with eyes. If contact occurs, rinse

thoroughly with water.

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Lotion
• Topical

Inactive ingredients

Water, Avocado Butter, Mineral Oil, Petrolatrum, Glycerin, Pentaerythritol Tetrakis, Stearic Acid, Vitamin E Oil, Steareth 2, Steareth 21, Sorbitan Stearate, Sorbitan Oleate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 80, Cetyl Alcohol, Polysorbate 20, Fragrance

• Clean the skin thoroughly before applying cream.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excesive drying of the skin may occur, start with one application daily. Gradually increase to two or three times daily if needed or as directed by a doctor.
• If botherome dryness or peeling occurs, reduce application to once a day or every other day.

Package Label - Principal Display Panel

SALICYLIC ACID 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67146-0129
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 g  in 0.25 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROGENATED AVOCADO OIL (UNII: JA69U4B4XI)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARETH-21 (UNII: 53J3F32P58)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67146-0129-2	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2022	06/26/2023

Labeler - Alps South, LLC (824697569)

Establishment
Name	Address	ID/FEI	Business Operations
Alps South LLC		824697569	manufacture(67146-0129)

Revised: 7/2023

Document Id: ff97c871-ae31-2c2a-e053-6394a90aecba

34390-5

Set id: b371db83-f557-fb64-e053-2a95a90aa536

Version: 3

Effective Time: 20230703