ENCARE- nonoxynol-9 insert
Blairex 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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Drug Facts

Active ingredient (in each insert)

Nonoxynol-9 100 mg.

Purpose

Vaginal Contraceptive

Use

for the prevention of pregnancy.

Warnings

For vaginal use only
Not for rectal (anal) use

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.

Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control.

When using this product

you may get vaginal irritation (burning, itching, or a rash)

Stop use and ask a doctor if

you or your partner get burning, itching, a rash or other irritation of the vagina or penis

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

at least 10 minutes prior to intercourse: remove the protective wrap and insert Encare into the vagina (see diagram on package insert). Each Encare insert gives you one full hour of protection.
may be used with: condom or diaphragm for added protection.
before use: read all directions and special warnings on this package and the insert inside.

Other information

when used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate, the risk of catching or spreading HIV, the virus that causes AIDS
store at 15-30°C (59-86°F)
keep away from excessive heat and moisture.

Inactive ingredients

polyethylene glycols, sodium bicarbonate, sodium citrate, tartaric acid.

Manufactured for: Blairex Laboratories, Inc. P.O. Box 2127 Columbus, IN 47202 USA

Telephone Questions or comments? Call TOLL FREE 1-800-252-4739
www.encare.net

Principal Display Panel - Carton Label

NDC 50486-221-18

with Nonoxynol-9

The Spermicide Doctors Recommend Most

Encare®

Vaginal contraceptive inserts
for prevention of pregnancy

No Hormonal Side Effects

Easy To Use
Individually Wrapped
Convenient To Carry

18 INSERTS

Principal Display Panel - Carton Label

NDC 50486-221-12

with Nonoxynol-9

The Spermicide Doctors Recommend Most

Encare®

Vaginal contraceptive inserts
for prevention of pregnancy

No Hormonal Side Effects

Easy To Use
Individually Wrapped
Convenient To Carry

12 INSERTS

Principal Display Panel - Carton Label

Birth Control
Women Trust

NDC 50486-221-13

with Nonoxynol-9 The Spermicide
Doctors Recommend Most

Encare®

Vaginal contraceptive
inserts for the
prevention of pregnancy

No
Hormonal
Side
Effects

Easy To Use
Individually Wrapped
Convenient To Carry

12 INSERTS

ENCARE
nonoxynol-9 insert

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50486-221
Route of Administration	VAGINAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
nonoxynol-9 (UNII: 48Q180SH9T) (nonoxynol-9 - UNII:48Q180SH9T)	nonoxynol-9	100 mg

Ingredient Name	Strength
Inactive Ingredients
polyethylene glycol 1000 (UNII: U076Q6Q621)
polyethylene glycol 1450 (UNII: OJ4Z5Z32L4)
tartaric acid (UNII: W4888I119H)
sodium citrate (UNII: 1Q73Q2JULR)
sodium bicarbonate (UNII: 8MDF5V39QO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50486-221-18	3 in 1 CARTON	09/01/1999	01/01/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:50486-221-12	2 in 1 CARTON	09/01/1999	01/01/2020
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:50486-221-13	2 in 1 CARTON	09/01/1999	01/01/2020
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/01/1999	01/01/2020

Labeler - Blairex Laboratories, Inc. (092575133)

Revised: 9/2013

Document Id: b17fbc07-781a-4916-9fc0-cdc0af924f84

Set id: a5d78ff6-31af-4c46-91b0-b7e5d40c1153

Version: 2

Effective Time: 20130903

Blairex Laboratories, Inc.