Rezamid lotion

Active ingredients

SULFUR 5%

RESORCINOL 2%

Purpose

ACNE TREATMENT LOTION

Use

DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

Warnings

  • FOR EXTERNAL USE ONLY

Otc - do not use section

DO NOT USE

  • ON BROKEN SKIN
  • ON LARGE AREAS OF THE BODY

Otc - when using section

WHEN USING THIS PRODUCT

  • APPLY TO AFFECTED AREAS ONLY
  • DO NOT GET INTO EYES
  • 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

Otc - stop use section

STOP USE AND ASK A DOCTOR IF

  • IF SKIN IRRITATION OCCURS OR GETS WORSE

Otc - keep out of reach of children section

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Directions

  • shake very well before using
  • 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 neededoras directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

water, SD-40 alcohol 28%, zinc oxide, talc, titanium dioxide, propylene glycol, attapulgite, lauramide DEA, iron oxides, sodium bisulfite, PEG-8 laurate, parachlorometaxylenol, hydroxyethylcellulose, sodium chloride, sodium polynapthalene sulfonate, EDTA, methyl paraben, xanthan gum, butylparaben, fragrance, simethicone.

Ingredients and appearance - Product information

Rezamid lotion- Sulfur and resorcinol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11086-022
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Sulfur ( UNII: 70FD1KFU70)( Sulfur - UNII: 70FD1KFU70 ) 5 gin 100 mL
Resorcinol ( UNII: YUL4LO94HK)( Resorcinol - UNII: YUL4LO94HK ) 2in 100 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Alcohol ( UNII: 3K9958V90M)
Zinc oxide ( UNII: SOI2LOH54Z)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)
Propylene glycol ( UNII: 6DC9Q167V3)
Attapulgite ( UNII: U6V729APAM)
Lauric diethanolamide ( UNII: I29I2VHG38)
Ferric oxide red ( UNII: 1K09F3G675)
Sodium bisulfite ( UNII: TZX5469Z6I)
Peg-8 laurate ( UNII: 762O8IWA10)
Chloroxylenol ( UNII: 0F32U78V2Q)
Hydroxyethyl cellulose (140 mpa.s at 5%) ( UNII: 8136Y38GY5)
Sodium chloride ( UNII: 451W47IQ8X)
Sodium naphthalenesulfonate ( UNII: D3F8YRX7TP)
Edetic acid ( UNII: 9G34HU7RV0)
Methylparaben ( UNII: A2I8C7HI9T)
Xanthan gum ( UNII: TTV12P4NEE)
Butylparaben ( UNII: 3QPI1U3FV8)
Dimethicone ( UNII: 92RU3N3Y1O)
Silicon ( UNII: Z4152N8IUI)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 11086-022-01 56.7mL in 1 BOTTLE 2013/10/30

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part333D USA 2013/10/30

Labeler - Summers Laboratories Inc( 002382612)

Establishment

Name ID/FEI Business Operations
Summers Laboratories Inc 002382612 manufacture( 11086-022), pack( 11086-022)

Package label.principal display panel