CLIXIT SKIN CARE ACNE DRYING- sulfur acne treatment 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

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 areas with thin layer two or three times a 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, Magnesium Aluminum Silicate, Salicylic Acid, Zinc Oxide.

QUESTIONS

Call 844 425 4948

Outer Box

DRYING LOTION BOX

Drying Lotion Label

Clixit Drying Lotion Label

CLIXIT SKIN CARE ACNE DRYING
sulfur acne treatment suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76348-447
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ZINC OXIDE (UNII: SOI2LOH54Z)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76348-447-02	1 in 1 BOX	10/02/2019
1	NDC:76348-447-01	28 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	10/02/2019

Labeler - Renu Laboratories, Inc. (945739449)

Name	Address	ID/FEI	Business Operations
Establishment
Renu Laboratories		945739449	manufacture(76348-447)

Revised: 10/2019

Document Id: 9405f298-f039-1ca8-e053-2a95a90a307d

Set id: 9405f298-f038-1ca8-e053-2a95a90a307d

Version: 1

Effective Time: 20191003

Renu Laboratories, Inc.