CLASSIC CONTROL ANTIDANDRUFF- pyrithione zinc shampoo

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)

Available from:

Apollo Health and Beauty Care Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

to help prevent recurrence of flaking and itching associated with dandruff.

Authorization status:

OTC monograph final

Summary of Product characteristics

CLASSIC CONTROL ANTIDANDRUFF- PYRITHIONE ZINC SHAMPOO
APOLLO HEALTH AND BEAUTY CARE INC.
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Pyrithione Zinc 1%
PURPOS E
Anti-dandruff
US ES
to help prevent recurrence of flaking and itching associated with
dandruff.
WARNINGS
For external use only.
WHEN USING THIS PRODUCT
avoid contact with eyes. If contact occurs, rinse eyes thoroughly with
water.
Stop use and ask a doctor if
condition worsens or does not improve after regular use of this
product as directed.
_Keep 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 a week or as directed by a
doctor.
For maximum dandruff control, use every time you shampoo.
Wet hair, massage onto scalp and rinse. Repeat if desired.
OTHER INFORMATION
Store at room temperature.
INACTIVE INGREDIENTS
Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Acrylates
Copolymer, Glycol Distearate,
Cocamidopropyl Betaine, Laureth-4, Fragrance (Parfum), Sodium
Hydroxide, Tetrasodium EDTA,
Cocamide MEA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue
1 (CI 42090), Red 33 (CI
17200).
LABEL COPY
CLASSIC CONTROL ANTIDANDRUFF
pyrithione zinc shampoo
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 3148 -413
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9
53O2RHZ5)
PYRITHIONE ZINC
10 mg in 1 mL
Apollo Health and Beauty Care Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
METHACRYLIC ACID - METHYL METHACRYLATE CO PO LYMER ( 1:1) (UNII:
74G4R6 TH13)
GLYCO L DISTEARATE (UNII: 13W7MDN21