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 Drying Lotion Box Cropped DL Label

CLIXIT ACNE DRYING
sulfur acne lotion suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76348-440
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2.8 g in 28 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
SALICYLIC ACID (UNII: O414PZ4LPZ)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76348-440-02	1 in 1 BOX	09/12/2019
1	NDC:76348-440-01	112 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	09/09/2019

Labeler - RENU LABORATORIES, INC. (945739449)

Registrant - RENU LABORATORIES, INC. (945739449)

Name	Address	ID/FEI	Business Operations
Establishment
RENU LABORATORIES, INC.		945739449	manufacture(76348-440)

Revised: 9/2019

Document Id: 925e7f99-4d66-0576-e053-2995a90aa47f

Set id: 925e7f99-4d65-0576-e053-2995a90aa47f

Version: 1

Effective Time: 20190912

RENU LABORATORIES, INC.