CLIXIT ACNE DRYING- sulfur acne lotion suspension

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

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Active ingredient:
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
RENU LABORATORIES, INC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Acne Treatment Use: For treatment of acne. Healing and drying of acne. Penetrates pores to control acne. Helps prevent breakouts.
Authorization status:
OTC monograph final
Authorization number:
76348-440-01, 76348-440-02

CLIXIT ACNE DRYING- sulfur acne lotion suspension

RENU LABORATORIES, 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.

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CLIXIT ACNE DRYING LOTION

Active Ingredient

Sulfur Colloidal 10%

Purpose

Acne Treatment

Uses

Use: For treatment of acne. Healing and drying of acne. Penetrates pores to control acne. Helps prevent

breakouts.

Warnings:

For external use only.

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.

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Store at room temperature.

Directions:

Clean the skin thoroughly before

using. Cover affected area with thin layer two or three times per day.

Do not use on broken skin or large areas of skin. If bothersome dryness or peeling occurs, reduce

application to once a day or every other day.

Inactive Ingredients:

Camphor, Deionized Water, Hippophae Rhamnoides (Seaberry) Fruit and Seed Oil, Iron Oxide,

Isopropyl Alcohol, Magesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

QUESTIONS?

Call 844 425 4948

Clixit Drying Lotion Box

Cropped DL Label

CLIXIT ACNE DRYING

sulfur acne lotion suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:76 348 -440

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

2.8 g in 28 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41)

ZINC O XIDE (UNII: SOI2LOH54Z)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

HIPPO PHAE RHAMNO IDES FRUIT O IL (UNII: TA4JCF9 S1J)

HIPPO PHAE RHAMNO IDES SEED O IL (UNII: T53SBG6 741)

SALICYLIC ACID (UNII: O414PZ4LPZ)

MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:76 348 -440 -0 2

1 in 1 BOX

0 9 /12/20 19

RENU LABORATORIES, INC.

1

NDC:76 348 -440 -0 1

112 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

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 9 /0 9 /20 19

Labeler -

RENU LABORAT ORIES, INC. (945739449)

Registrant -

RENU LABORAT ORIES, INC. (945739449)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

RENU LABORATORIES, INC.

9 45739 449

ma nufa c ture (76 348 -440 )

Revised: 9/2019

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