Salicylic Acid 6 Percent (Page 2 of 2)

Pregnancy (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. Salicylic Acid 6% (w/w) Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from the mother’s use of Salicylic Acid 6% (w/w) Shampoo, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data is available concerning potential carcinogenic or reproductive effects of Salicylic Acid 6% (w/w) Shampoo. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

Adverse Reactions to Salicylic Acid 6 Percent

Excessive erythema and scaling conceivably could result from use on open skin lesions.

OVERDOSAGE

See WARNINGS.

DOSAGE AND ADMINISTRATION

Wet hair and apply Salicylic Acid 6% (w/w) Shampoo to the scalp. Work into a lather then rinse. Repeat the treatment as needed until the condition clears. Once clearing is apparent, the occasional use of Salicylic Acid 6% (w/w) Shampoo will usually maintain the remission.

HOW SUPPLIED

Salicylic Acid 6% (w/w) Shampoo is available in 177mL plastic bottles (NDC 42546-279-06).

Store at controlled room temperature 20°-25°C (68°-77°F). Do not freeze.

Manufactured for:
PruGen Pharmaceuticals
18899 N Thompson Peak Pkwy
Scottsdale, AZ 85255
Rev 4.0

PRINCIPAL DISPLAY PANEL — 177 ml Bottle Box

NDC 42546-279-06

SALICYLIC ACID
6% (w/w)
SHAMPOO

Rx Only

FOR DERMATOLOGICAL USE ONLY

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE

177 ml

PRUGEN®
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL -- 177 ml Bottle Box
(click image for full-size original)
SALICYLIC ACID 6 PERCENT
salicylic acid shampoo
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42546-279
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
salicylic acid (salicylic acid) salicylic acid 6 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
water
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM LAURETH-3 SULFATE
TROLAMINE
QUATERNIUM-22
COCAMIDOPROPYL BETAINE
BEHENTRIMONIUM METHOSULFATE
PROPYLPARABEN
METHYLPARABEN
GLYCERIN
EDETATE DISODIUM
CHAMOMILE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42546-279-06 1 BOTTLE in 1 BOX contains a BOTTLE
1 177 mL in 1 BOTTLE This package is contained within the BOX (42546-279-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2009
Labeler — PruGen, Inc. (929922750)
Establishment
Name Address ID/FEI Operations
SUMMERS LABORATORIES, INC. 002382612 MANUFACTURE (42546-279)

Revised: 12/2017 PruGen, Inc.

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