SOFTSHEENCARSON MAGIC BUMP RESCUE SPOT TREATMENT- salicylic acid lotion

SoftSheenCarson Magic Bump Rescue Spot Treatment by

Drug Labeling and Warnings

SoftSheenCarson Magic Bump Rescue Spot Treatment by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Les Emballages Facoteck Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

- for the treatment of acne

- clears up acne blemishes and allows skin to heal

Warnings

For external use only

Flammable until dry

Do not use near fire, flame or heat.

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 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 denat., glycerin, propylene glycol, triethanolamine, acrylates/c10-30 alkyl acrylate crosspolymer, capryloyl salicylic acid, disodium EDTA, zinc gluconate, menthol, benzyl salicylate, benzyl alcohol, linalool, fragrance

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOFTSHEENCARSON MAGIC BUMP RESCUE SPOT TREATMENT 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-933
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
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
MENTHOL (UNII: L7T10EIP3A)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-933-01	1 in 1 CARTON	11/01/2013
1		10 mL in 1 TUBE, WITH APPLICATOR; 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	11/01/2013

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Les Emballages Facoteck Inc.		245423439	manufacture(49967-933)