OTC Medication Information: OVERNIGHT RELIEF Gel-Patch

OVERNIGHT RELIEF GEL-PATCH- menthol patch
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

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.

Active ingredient

Menthol 5% w/w …… Purpose: Topical analgesic

Purpose

Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthrits
  • strains
  • bruises
  • sprains

Warnings

For external use only

When using this prudocts:

• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask doctor

Stop use and ask a doctor if:
• you experience pain, swelling or blistering of the skin
• condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
• arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding, ask a health professional before use.

When using

When using this prudocts:

• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Do not use

• do not apply to wounds or damaged skin
• do not apply to irritated skin or if excessive irritation develops
• do not bandage tightly or use with heating pad or device

Stop use

Stop use and ask a doctor if : Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

Pregnancy or breast feeding

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions

• adults and children 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed gel-patch to site of pain. Carefully remove remaining film while pressing the gel-patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 3 to 4 times daily.
• children under 12 years of age: consult a physician • wash hands after use with cool water

Dosage forms & strengths

This is patch dosage form.

The active ingredient strength is 5%.

Inactive ingredients

Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate, Mineral Oil, Lavender Essential Oil, Polysorbate 80, PVP, Petrolatum, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Kaolin, Carboxymethylcellulose Sodium, Titanium Dioxide, L-Tartaric Acid, Benzalkonium Chloride, Lauralkonium Chloride

Questions or comments

Questions or comments : 86-21-31166566

Other information

• store at 20-25℃ (68-77℉)

• store in a cool dry place away from direct sunlight

Package label. Principal display panel

139-01
(click image for full-size original)
139-05
(click image for full-size original)

OVERNIGHT RELIEF GEL-PATCH menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73557-139
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 0.05 g in 1 g
Inactive Ingredients
Ingredient Name Strength
KAOLIN 0.001 g in 1 g
TARTARIC ACID 0.001 g in 1 g
WATER 0.3095 g in 1 g
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS 0.0015 g in 1 g
PROPYLENE GLYCOL 0.06 g in 1 g
POLYACRYLIC ACID (250000 MW) 0.2 g in 1 g
CARBOXYMETHYLCELLULOSE SODIUM 0.001 g in 1 g
SODIUM POLYACRYLATE (2500000 MW) 0.05 g in 1 g
TITANIUM DIOXIDE 0.001 g in 1 g
MINERAL OIL 0.03 g in 1 g
PETROLATUM 0.002 g in 1 g
BENZALKONIUM CHLORIDE 0.001 g in 1 g
LAURALKONIUM CHLORIDE 0.001 g in 1 g
POLYSORBATE 80 0.018 g in 1 g
GLYCERIN 0.24 g in 1 g
POVIDONE K30 0.012 g in 1 g
LAVENDER OIL 0.02 g in 1 g
EDETATE DISODIUM 0.001 g in 1 g
Product Characteristics
Color brown Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73557-139-05 5 PATCH in 1 BOX contains a PATCH (73557-139-01)
1 NDC:73557-139-01 3 g in 1 PATCH This package is contained within the BOX (73557-139-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/22/2021
Labeler — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Registrant — Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Establishment
Name Address ID/FEI Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd. 546872672 manufacture (73557-139), label (73557-139)

Revised: 11/2021 Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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