RE-FRESH SCALP CARE- salicylic acid shampoo

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Conopco, Inc. d/b/a/ Unilever
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-dandruff • Helps prevent and control recurrence of itching, flaking and irritation associated with dandruff.
Authorization status:
OTC monograph final
Authorization number:
64942-1636-1

RE-FRESH SCALP CARE- salicylic acid shampoo

Conopco, Inc. d/b/a/ Unilever

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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RE-fresh Scalp Care Coconut + Soothe Anti-Dandruff Shampoo

RE-FRESH SCALP CARE COCONUT + SOOTHE ANTI-DANDRUFF SHAMPOO - salicylic

acid liquid

RE-fresh Scalp Care Coconut + Soothe Anti-Dandruff Shampoo

Drug Facts

Active ingredient

Salicylic Acid (2.0%)

Purpose

Anti-dandruff

Use

Helps prevent and control recurrence of itching, flaking and irritation associated with dandruff.

Warnings

For external use only

When using this product: Avoid contact with eyes. If contact occurs, rinse eyes thoroughtly with

water.

Stop use and ask a doctor if: Condition worsens or does not improve after regular use of this

product as directed.

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison

Control Center right away.

Directions

For best results use at least twice per week or as directed by a doctor. Massage into scalp and hair.

Rinse.

Inactive Ingredients

Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycerin, Sodium Chloride, Cocos

Nucifera (Coconut) Water, Cocos Nucifera (Coconut) Fruit Extract, Salix Alba (Willow) Bark Extract,

Rosmarinus Officinalis (Rosemary) Leaf Extract, Arctium Lappa Root Extract, Ginkgo Biloba Leaf

Extract, Salvia Officinalis (Sage) Leaf Extract, Hippophae Rhamnoides Fruit Extract, Citric Acid,

Fragrance (Parfum), Sodium Benzoate, Glycol Distearate, Polyquaternium-10, Disodium EDTA,

Cocamide MEA, Benzyl Alcohol, Benzyl Salicylate, Coumarin, Limonene.

Questions/comments?

Call toll-free 1-800-671-3998

Package

RE-FRESH SCALP CARE

salicylic acid shampoo

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 49 42-16 36

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

2 g in 10 0 mL

Conopco, Inc. d/b/a/ Unilever

Inactive Ingredients

Ingredient Name

Stre ng th

LIMO NENE, ( +) - (UNII: GFD7C8 6 Q1W)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

CO CO NUT WATER (UNII: 26 7F5Y8 1NT)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

GINKGO (UNII: 19 FUJ2C58 T)

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

GLYCO L DISTEARATE (UNII: 13W7MDN21W)

PO LYQ UATERNIUM-10 ( 10 0 0 MPA.S AT 2 %) (UNII: GMR4PEN8 PK)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

BENZYL SALICYLATE (UNII: WAO5MNK9 TU)

CO UMARIN (UNII: A4VZ22K1WT)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 49 42-16 36 -

40 0 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/10 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

10 /19 /20 18

Labeler -

Conopco, Inc. d/b/a/ Unilever (001375088)

Revised: 3/2019

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