FEMININE PAIN RELIEF- menthol, unspecified form patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)
Available from:
Unexo Life Sciences, Private Limited
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of minor aches and pains in lower back and abdomen associated with cramps. Topical Analgesic
Authorization status:
OTC monograph not final
Authorization number:
71391-130-05

FEMININE PAIN RELIEF- menthol, unspecified form patch

Unexo Life Sciences, Private Limited

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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FEMININE PAIN RELIEF

DRUG FACTS

Us es

For temporary relief of minor aches and pains in lower back and abdomen associated with cramps.

Active Ingredient

Menthol 10%

Purpos e

Topical Analgesic

Warnings

For External Use Only.

Do not use otherwise than as directed.

Do Not Use

On open wounds, cuts, eyes and face

With a heating pad

When using this product

Avoid contact with eyes and mucous membranes

Do not bandage tightly

Ask Your Doctor Before Use if you have

redness over the affected area

have sensitive skin

are pregnant or breast-feeding

Stop Use and Ask Your Doctor

If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within

a few days

If abnormal skin irritation occurs after usage

Keep Out of Reach of Children.

If swallowed, seek medical help or contact a Poison Control Center right away.

Directions

For use by Adults and Children 12 years of age and older

Apply to the affected area no more than 2 times a day

Dry skin completely at application area, before applying the patch

Open pouch and remove patch

Peel off protective film and apply sticky side to affected area

If applied on hairy skin, remove gently using mild warm water

Patch once used, cannot be re-pasted or reused

Dispose properly after use

Other Information

Store at room temperature below 80°F (27°C)

Inactive Ingredients

Adhesive Plaster, Eucalyptus Oil

Manufactured By:

Unexo Life Sciences Pvt. Ltd.

B-16, Sector 4, Bawana Industrial Area,

Delhi -110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch

PLEASE RESEAL AFTER OPENING

NDC: 71391-130-05

unexo

LIFE SCIENCES

FEMININE

PAIN RELIEF

PATCH

PACK OF

PATCHES

SOOTHE

PERIOD CRAMPS

MEDICATED PATCH

FAST ACTING

APPLY FOR 8-12 HOURS

Unexo Life Sciences, Private Limited

FEMININE PAIN RELIEF

menthol, unspecified form patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7139 1-130

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED FORM -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Euca lyptus O il (UNII: 2R0 4ONI6 6 2)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7139 1-130 -0 5

5 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 1/19 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 1/19 /20 19

Labeler -

Unexo Life Sciences, Private Limited (872260479)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Unexo Life Sciences, Private Limited

8 7226 0 479

MANUFACTURE(7139 1-130 )

Revised: 3/2019

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