SCALP CV68- salicylic acid cream

Scalp by

Drug Labeling and Warnings

Scalp by is a Otc medication manufactured, distributed, or labeled by Pharmco Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 3%

Purpose

For the relief of Seborrheic Dermatitis, Dandruff, and/or Psoriasis.

Uses

For the relief of symptoms associated with seborrheic dermatitis, dandruff, and/or psoriasis, including: itching

• scaling
• flaking
• redness
• irritation of the skin.

Helps prevent recurrence.

Warnings

For external use only. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

• If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
• If condition covers a large area of the body, consult your doctor before using this product. If this product causes increased irritation, discontinue use and seek medical advice.

Keep out of reach of children. If swallowed get medical help or call a poison control center immediately.

Directions

Use only as directed. Apply to affected areas one to four times daily or as directed by a doctor. Massage well into affected areas. Optimally, this product should be applied to the scalp and left overnight.

Other Information

• Store at room temperature.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, C12-15 Alkyl Benzoate, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Prunus Amigdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Triethanolamine, Water.

Questions or comments?

call 1.800.635.0712 Monday through Friday 8:00 AM to 4:30 PM

SPL UNCLASSIFIED SECTION

Manufactured by: Pharmco Laboratories, Inc.
3520 South St. Titusville, FL 32780

PRINCIPAL DISPLAY PANEL - 96 g Bottle Label

PHARMCO
SKINCARE LABS

Scalp Cream

Helps Control
SEBORRHEIC DERMATITIS,
DANDRUFF & PSORIASIS

Net wt. 3.4 oz. (96 g)

INGREDIENTS AND APPEARANCE

SCALP   CV68
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58400-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
Sodium Hydroxide (UNII: 55X04QC32I)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58400-020-01	96 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M032	01/01/2018

Labeler - Pharmco Laboratories, Inc. (096270814)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmco Laboratories, Inc.		096270814	MANUFACTURE(58400-020) , LABEL(58400-020) , PACK(58400-020)