OLP ACNE CLEAR- salicylic acid gel

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

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
OHIO LAB PHARMA
INN (International Name):
SALICYLIC ACID
Composition:
SALICYLIC ACID 5 mg in 1 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne treatment For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to heal. if you have sensitive skin or are sensitive to salicylic acid
Authorization status:
OTC monograph final
Authorization number:
70648-300-01

OLP ACNE CLEAR- salicylic acid gel

OHIO LAB PHARMA

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.

----------

ACTIVE INGREDIENT

Salicylic Acid 0.5% w/w.

PURPOSE

Acne treatment

USES

For the treatment of acne. Dries and clears acne pimples, blackheads and whiteheads and allows skin to

heal.

DO NOT USE

if you have sensitive skin or are sensitive to salicylic acid

DIRECTIONS

Morning and evening, after a thorough cleansing of the skin, apply acne clear gel locally on cutanous

imperfections. Then apply the usual day or night cream. Renew application 1 to 3 times daily.

WARNINGS

For external use only. Using other topical acne medications at the same time or immediately following

use of this product may increase dryness or irritation of the skin. If this occurs, only one medication

should be used unless directed by a doctor. Avoid direct contact with the eyes. If product gets into the

eyes, rinse liberally with water. Discontinue use if skin irritation develops or increases. If irritation

persists, consult a doctor.

WHEN USING THIS PRODUCT

Avoid contact with eyes, lips, and mouth.

KEEP OUT OF REACH OF CHILDREN

if swallowed, get medical help or contact poison control center right away

carbomer interpolymer type A, trolamine, vitamin E, propylene glycol, water, isopropyl alcohol, methyl

paraben, EDTA, propyl paraben, DMDM hydantoin

OTHER INFORMATION

store at 15-30 C ( 59-86 F)

close cap tightly after use

keep away from heat

QUESTIONS

ohiolabpharma.us

PACKAGE LABEL

OLP ACNE GEL

OLP ACNE CLEAR

salicylic acid gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 48 -30 0

Route of Administration

TOPICAL

OHIO LAB PHARMA

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

SALICYLIC ACID

5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

.ALPHA.-TO CO PHERO L (UNII: H4N8 55PNZ1)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 6 48 -30 0 -

1 in 1 CARTON

0 2/0 1/20 17

1

20 g in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

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 rt333D

0 2/0 1/20 17

Labeler -

OHIO LAB PHARMA (080215854)

Registrant -

OHIO LAB PHARMA (080215854)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

OHIO LAB PHARMA

0 8 0 2158 54

ma nufa c ture (70 6 48 -30 0 )

Revised: 11/2018

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