CLEAN AND CLEAR DUAL ACTION MOISTURIZER- salicylic acid lotion

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

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Active ingredient:
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)
Available from:
Johnson & Johnson Consumer Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne medication for the management of acne
Authorization status:
OTC monograph final
Authorization number:
69968-0589-4

CLEAN AND CLEAR DUAL ACTION MOISTURIZER- salicylic acid lotion

Johnson & Johnson Consumer 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.

----------

Clean & Clear

dual action moisturizer

Drug Facts

Active ingredient

Salicylic Acid (0.5%)

Purpos e

Acne medication

Us e

for the management of acne

Warnings

For external use only.

When using this product

Skin irritation and dryness is more likely to occur if you use another topical acne medication at the

same time. If irritation occurs, only use one topical acne medication at a time.

Rinse right away with water if it gets in eyes.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right

away.

Directions

clean the skin thoroughly before applying this product

cover the entire affected area with a thin layer one to three times daily

because excessive drying of the skin may occur, start with one application daily, then gradually

increase to two or three times daily if needed or as directed by a doctor

if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

Store at room temperature

Inactive ingredients

Water, Dicaprylyl Ether, Cetearyl Alcohol, Glycerin, Neopentyl Glycol, Diethylhexanoate,

Dimethicone, Methyl Gluceth-20, Menthyl Lactate, Aluminum Starch Octenylsuccinate, Ceteth-10

Phosphate, Dicetyl Phosphate, Steareth-20, Steareth-2, Neopentyl Glycol Diisostearate, Fragrance,

Sodium Hydroxide, Hydrogenated Lecithin, Xanthan Gum, Magnesium Aluminum Silicate, Disodium

EDTA, BHT, Titanium Dioxide

®

Ques tions ?

Call toll-free 877-754-6411 or 215-273-8755 (collect) www.CleanandClear.com

Distributed by:

JOHNSON & JOHNSON

CONSUMER INC.

Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Clean

&

Clear

dual action

mois turizer

salicylic acid acne medication

OIL-FREE

STEP 1 2 3

moisturizes dry skin, treats

& helps prevent pimples

Johnson & Johnson

4 FL. OZ.

(118mL)

CLEAN AND CLEAR DUAL ACTION MOISTURIZER

salicylic acid lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 9 6 8 -0 58 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Sa licylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)

Salicylic Acid

5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Dica prylyl Ether (UNII: 77JZM5516 Z)

Ceto stea ryl Alco ho l (UNII: 2DMT128 M1S)

Glycerin (UNII: PDC6 A3C0 OX)

Neo pentyl Glyco l Diethylhexa no a te (UNII: U6 8 ZV6 W6 2C)

Dimethico ne (UNII: 9 2RU3N3Y1O)

Methyl Gluceth-2 0 (UNII: J3QD0 LD11P)

Menthyl La cta te, ( -) - (UNII: 2BF9 E6 5L7I)

Aluminum Sta rch O ctenylsuccina te (UNII: I9 PJ0 O6 29 4)

Ceteth-10 Pho spha te (UNII: 4E0 5O5N49 G)

Dihexa decyl Pho spha te (UNII: 2V6 E5WN9 9 N)

Stea reth-2 0 (UNII: L0 Q8 IK9 E0 8 )

Stea reth-2 (UNII: V56 DFE46 J5)

Neo pentyl Glyco l Diiso stea ra te (UNII: 4M6 OQ34JWW)

So dium Hydro xide (UNII: 55X0 4QC32I)

Hydro g ena ted So ybea n Lecithin (UNII: H110 9 Z9 J4N)

Xa ntha n Gum (UNII: TTV12P4NEE)

Ma g nesium Aluminum Silica te (UNII: 6 M3P6 4V0 NC)

Edeta te Diso dium Anhydro us (UNII: 8 NLQ36 F6 MM)

Butyla ted Hydro xyto luene (UNII: 1P9 D0 Z171K)

Tita nium Dio xide (UNII: 15FIX9 V2JP)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 9 6 8 -0 58 9 -

118 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 1/20 19

Johnson & Johnson Consumer Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 3/0 1/20 19

Labeler -

Johnson & Johnson Consumer Inc. (002347102)

Revised: 4/2020

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