CONTRASEED- contraseed suppository 
International Trading Pharmaceutical Laboratories, Inc

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Boxed Warning Section

WARNING:
For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician.
This product does not protect against HIV AIDS or other STDs and may increase the risk of getting HIV from an infection partner. Do not use if you or your sex partner has HIV AIDS. if you do not know if you or your partner is infected, choose another form of birth control. When using this you may get vaginal irritation (burning, itching, or a rash). Stop Using and ask a Doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis. Keep this and all medicines out of reach of children.

Dosage and Administration

DIRECTIONS:
Tear off one suppository from the strip. Separate the two tabs of the white plastic protective wrap. With thumb and forefinger of each hand grasp the tabs and peel tabs downward, unwrapping the suppository. Insert suppository deeply into the vagina. ContraSeed should be inserted 15 minutes before intercourse, however, ContraSeed is also effective when inserted up to 1 hour before intercourse. If intercourse is delayed for more than 1 hour after ContraSeed is inserted, or if intercourse is repeated, then another suppository must be inserted.



INGREDIENTS:
Each ContraSeed suppository contains 100 mg of Nonoxynol9 in a polyethylene glycol base.

STORAGE:
Keep ContraSeed at room temperature (not over 86F or 30C).

Warning

WARNING:
For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician.
This product does not protect against HIV AIDS or other STDs and may increase the risk of getting HIV from an infection partner. Do not use if you or your sex partner has HIV AIDS. if you do not know if you or your partner is infected, choose another form of birth control. When using this you may get vaginal irritation (burning, itching, or a rash). Stop Using and ask a Doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis. Keep this and all medicines out of reach of children.

Inactive Ingredient

Polyethylene glycol base 1450

Indication and Usage

DIRECTIONS:
Tear off one suppository from the strip. Separate the two tabs of the white plastic protective wrap. With thumb and forefinger of each hand grasp the tabs and peel tabs downward, unwrapping the suppository. Insert suppository deeply into the vagina. ContraSeed should be inserted 15 minutes before intercourse, however, ContraSeed is also effective when inserted up to 1 hour before intercourse. If intercourse is delayed for more than 1 hour after ContraSeed is inserted, or if intercourse is repeated, then another suppository must be inserted.

OTC Purpose

For safe and effective prevention of Pregnancy

Out of Reach of Childern

Keep this and all medicines out of reach of children.

Active Ingredient


INGREDIENTS:
Each ContraSeed suppository contains 100 mg of Nonoxynol9 in a polyethylene glycol base.


For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician.

Label

DIRECTIONS:
Tear off one suppository from the strip. Separate the two tabs of the white plastic protective wrap. With thumb and forefinger of each hand grasp the tabs and peel tabs downward, unwrapping the suppository. Insert suppository deeply into the vagina. ContraSeed should be inserted 15 minutes before intercourse, however, ContraSeed is also effective when inserted up to 1 hour before intercourse. If intercourse is delayed for more than 1 hour after ContraSeed is inserted, or if intercourse is repeated, then another suppository must be inserted.


WARNING:
For Vaginal use only. Not for rectal (anal) use. Do not take orally. If irritation is experienced by either of the partner, discontinue use if irritation persist, consult your physician.
This product does not protect against HIV AIDS or other STDs and may increase the risk of getting HIV from an infection partner. Do not use if you or your sex partner has HIV AIDS. if you do not know if you or your partner is infected, choose another form of birth control. When using this you may get vaginal irritation (burning, itching, or a rash). Stop Using and ask a Doctor if you or your partner get burning, itching, a rash or other irritation of the vagina or penis. Keep this and all medicines out of reach of children.


INGREDIENTS:
Each ContraSeed suppository contains 100 mg of Nonoxynol9 in a polyethylene glycol base.

STORAGE:
Keep ContraSeed at room temperature (not over 86F or 30C).

PackageLabel

CONTRASEED 
contraseed suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61230-001
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Nonoxynol-9 (UNII: 48Q180SH9T) (Nonoxynol-9 - UNII:48Q180SH9T) Nonoxynol-9100 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) 2150 mg
Product Characteristics
Colorwhite (White-Transperent) Score    
ShapeBULLETSize30mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61230-001-021 in 1 BOX
112 in 1 PACKET
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/26/201503/31/2017
Labeler - International Trading Pharmaceutical Laboratories, Inc (808304844)
Establishment
NameAddressID/FEIBusiness Operations
International Trading Pharmaceutical Laboratories, Inc808304844label(61230-001)

Revised: 3/2015
 
International Trading Pharmaceutical Laboratories, Inc