SPECTRUM CONDOM 53mm MC

Manufacturer
Spectrum Pharmaceutical Distributors
Effective date
2025-10-30
Label type
OTC MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:52:10

Label at a glance#

ProductSPECTRUM CONDOM 53mm MC
Label structure2 sections

Label contents#

Full prescribing information#

SPECTRUM CONDOM 53mm MC

WARNINGS AND PRECAUTIONS SECTION

DIRECTIONS FOR USE BIRTH CONTROL GUIDE

Male Natural Rubber Latex Condoms


BEFORE INTERCOURSE
1. Carefully open the package so the condom does not tear. Do not unroll the condom before

CUPID Brand Male Natural Rubber Latex Condoms: are used for contraception and or prophylactic purposes (or help prevent pregnancy and the transmission of sexually transmitted infections).


1. Use a new condom for each act of sex.

If you do not want to get pregnant, there are many birth control options to choose from. Noone product is best for everyone. Some methods are more effective than others at preventng pregnancy.Check the pregnancy rates on this chart to get an idea of how effectve the product is at preventng pregnancy.

FDA-Approved Methods

Number of pregnancies expected (per 100 women)*

Use Some Risks or Side Effects* This chart does not list all of the risks and side effects for each product putng it on.

2. If you are not circumcised, pull back the foreskin. Put the condom on the end of the hard penis.
Note: If the condom is initally placed on the penis backwards, do not turn it around. Throw it

2. Tear open the package carefully. Do not use fingernails, teeth, or anything that can damage the condom.

3. Before any sexual contact, place the condom on the head of the erect penis with the rolled side

The pregnancy rates tell you the number of pregnancies expected per 100 women during the first year of typical use. Typical use shows how effectve the different methods are during actual use (including sometmes using a method in a way that is not correct or Patch 9 Put on a new patch each week for 3 weeks (21 total  Spotting/bleeding between periods Nausea, Breast tenderness, Headache  away and start with a new one.

3. Pinching the tp of the condom to squeeze out air, roll on the condom untl it reaches the base of the penis. Place the condom on the erect penis before any contact occurs between the penis and the out. Lesions, pre-ejaculate secretons, semen, vaginal secretons and blood can all transmit  infectous oganisms.

4. Unroll or pull the condom all the way to the base of the erect penis. If the condom doesn’t not consistent). The only sure way to avoid pregnancy is not to have any sexual contact. Talk to  your health care provider about the best method for you,  days).Don't put on a Skin Irritation patch during the  fourth week  partner’s body to assist in the preventon of sexually transmited infecton and pregnancy.

4. Check to make sure there is space at the tp and that the condom is not boken. With the condom unroll easily, it may be on backwards, damaged or too old. Throw it away and start over with a new  condom.

FDA-Approved

Number of Use Some Risks or Side Effects*

Vaginal Contraceptive Ring

9 Put the ring into the vagina yourself.

Vaginal discharge, discomfort in the vagina, mild irritation. on, insert the penis for intercourse.

AFTER INTERCOURSE
5. When withdrawing the penis after sex and soon after ejaculation, hold the rim of the condom to

5. Immediately after ejaculation, hold the rim of the condom in place and withdraw the penis while it is stll erect. Avoid spilling semen.
6. Dispose of a used condom by wrapping it in tssue and thowing it into the trash. Wash your hands with soap and water.Methods

pregnancies expected (per 100 women)*

This chart does not list all of the risks and side effects for each product Diaphragm with  Keep the ring in your Headache, Nausea, Mood vagina for 3 weeks & changes, Breast tenderness then  take it out for  one week.

keep the condom in place.
6.Remove the condom while the penis is stll hard. Be careful not to spill any semen on the woman’s genitals.


DISPOSAL OF THE CONDOM

7. If you have questons about birth control optons, partcularly because of health reasons for avoiding pregnancy, consult a health care provider.
Precautions:

Sterilization Surgery for Women
Sterilization Surgery

Less than - 1 Onetime Permanent.
Less than - 1 Onetime

Pain ,Bleeding, Infection or other complications after surgery Pain ,Bleeding, Infection Sponge with Spermicide

12 Must use every time you have sex
12-24 Must use every time you have sex

Irritation, Allergic reactions Urinary tract infection Irritation

Wrap the used condom in a piece of paper and throw it away safely where children cannot get hold of

Do not reuse latex condoms.
Store latex condoms in a cool, dry place (below 30ºC) and avoid exposure to direct for Men  procedure Permanent.

Cervical Cap with Spermicide

17-23

Must use every time you have sex

Irritation, Allergic reactions Abnormal Pap test it. Dispose in a closed rubbish bin, burry or burn. It may be disposed by throwing in a pit

latrine. Do not throw it in a flushing toilet.


WARNING! Use the condom only once. The Condom is made of Natural Rubber Latex, which might sunlight.

If the rubber material is sticky or brittle or obviously damaged, do not use the condom. If the color is uneven or changed, do not use the condom.

IUD Copper Less than - 1 Inserted by a healthcare provider. Lasts up to 10 years.

cramps, Heavier, Longer periods Spotting between periods Male Condom 18

Must use every time Irritation, Allergic reactions you have sex.
Provide Protection against some STIs.

cause allergic reactions including anaphylactic shock. Try to keep condoms in a cool, dry place. Do Make sure there is adequate lubrication. If you add lubricant, use a water-based lubricant.

IUD with Progestin Less than - 1 Inserted by a Irregular bleeding No periods

Female Condom 21 Must use every time Discomfort or pain not leave them in the sun or carry them in a wallet or back pocket under fricton for a long time.

Consult a doctor or pharmacist about the compatibility of topical medicines that might come in contact with the condom.


INSPECTING AND OPENING THE PACKET

[Manufacturers may identify one or more examples.] DO NOT USE OIL-BASED LUBRICANTS, such as those
made with petroleum jelly (e.g., Vaseline®), mineral oil, vegetable oil, or cold cream, as these may damage the condom.

healthcare provider. Lasts up to 3-5 years, depending on type Implantable Rod Less than - 1 Inserted by a (amenorrhea) Abdominal /pelvic pain

Menstrual Changes Weight gain Spermicide Alone  you have sex. Provide Protection against some STIs. 28 Must use every  during insertion or sex Burning Sensation, rash or itching  Irritation, Allergic reactions  Before sex, talk to your partner about using a condom. Do not use a condom that has expired. Check  Degree of STI Protection  healthcare provider. Acne  time you have sex  Urinary tract infection  the expiry date on the package. Do not use a condom if the packaging is torn or damaged, if the  condom is sticky or dried out, or if the color has changed. Discard that condom and use a new one  from an undamaged package. Open the packet and handle condoms carefully to avoid damage to the  condom by fingernails, jewelry, etc. Do not worry if you find a slippery substance in and on the  Latex condoms reduce the risk of transmitting STIs by providing a barrier against the source of the  infection.

Latex condoms are most effective against STIs such as HIV infection (AIDS) and gonorrhea Lasts up to 3 years.

Shot/Injection 6 Need a shot every 3 months Mood swings or depressed mood Headache  Loss of bone density. Irregular bleeding/

OTHER CONTRACEPTION
Emergency Contraceptives (EC): May be used if you did not use birth control or if your regular birth control fails (such as a condom breaks). It should no be used as a regular form of birth control. Emergency control. Emergency contraception prevents about 55-85% of predicated
pregnancies.

condom when opening the packet. Some condoms have a lubricant to make sex smoother.


LUBRICATION

that are spread by contact with the head of the penis.
Latex condoms are less effective against STIs such as Human Papillomavirus (HPV) and herpes.

bleeding between periods Headaches, Weight gain, Nervousness, Dizziness, Levonorgestrel 1.5mg (1 pill)  7 out of every 8 women who would have gotten  Swallow the pills as soon as possible  Menstrual changes Headache  Lower stomach (abdominal) pain Nausea, Vomiting,  1-Lubricaton is very important. The condom covered penis should slide easily in the partner’s body.

These STIs can also be spread by contact with infected skin that is not covered by the condom.

Abdominal discomfort

Levonorgestrel .75mg pregnant will no become within 3 days after Dizziness  Tiredness  Otherwise the condom may cause pain or may make the body more vulnerable to HIV, or may break.

If you believe you have an STI, contact a health care provider. For more information on latex Oral Contraceptives  9 Must swallow a  Spotting/bleeding between  (2 pill)  pregnant after taking this EC.  having unprotected sex 

Breast pain

2-Use only water-based lubricants, such as water, water-based lubricant, or spermicidal foam.
3-Do not use lubricants with oil in them, such as petroleum jelly, body lotions, baby oil, butter condoms or STIs, contact a health care provider or a public health agency. “ The Pill” (Combined Pill)  pill every day.

periods Nausea, Breast tenderness, Headache Ulipristal Acetate 6 or 7 out of every 10 Swallow the pills  women who would have within 5 days after  Headache Nausea Abdominal Pain Menstrual pain  mineral oil or cooking oil. Oil weakens latex condoms.

STANDARD

1 2 3 4

gotten pregnant will not having unprotected

Tiredness

Dizziness

4-Do not put anything into the vagina to make it drier.
IN CASE OF SLIPPING OR BREAKING

The Male Latex Condoms are produced based on ISO 4074 and WHO/UNFPA Male Latex Oral Contraceptives “The Pill”(Extended Continuous Use

9 Must swallow a pill every day. Spotting/bleeding between periods Nausea, Breast tenderness, Headache  become pregnant after taking this EC.

sex.

1- If you feel the condom might be slipping, check it with your hand. It is very important that the condom does not slip off during Sex
2-If the condom breaks, stop sex at once. Remove the torn condom and put on another.
3-If the condom breaks or leaks and the man has ejaculated, take acton to prevent pregnancy. Go to the nearest clinic for emergency contraception as soon as possible, within 72 hours of the breakage/leakage.

Condom Technical Specificaton.
5 6 7

Date of Issue: 23/05/2022

Combined Pill) Oral Contraceptives “ The Mini Pill” (Progestin Only)

9 Must swallow a pill at the same time every day.

Spotting/bleeding between periods Nausea, Breast tenderness, Headache

* For more information on the chance of getting pregnant while using a method or on the risks of a
specific product, please check the product label or Trussell, J (2011). ”Contraceptive failure in
the United States.” Contraception 83(5):397-404

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Male Natural Rubber Latex Condoms

1 pack contains 12 pieces

cartoncarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85823-400-01SPECTRUM CONDOM 53mm MC1 in 1 POUCH11
85823-400-01SPECTRUM CONDOM 53mm MC12 in 1 CARTON121

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85823-40085823-400-01

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.