OTC Medication Information: XtraCare Ice Cold Topical Analgesic Gel

XTRACARE ICE COLD TOPICAL ANALGESIC GEL- menthol gel
China Ningbo Shangge Cosmetic Technology Corp

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 Ingredients: Purpose

Menthol 1.25% ……………………… Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints.

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

XtraCare® Ice Cold Topical Analgesic Gel

Net Wt 8 oz (227 g)

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use  if condition worsens, persists for more than 1 week or tends to recur.

Directions

  • see important warnings under “When using this product”
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician

Inactive Ingredients:

camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Other information:  store at 20o to 25oC (68o to 77oF)

Questions/Comments?  1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

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XTRACARE ICE COLD TOPICAL ANALGESIC GEL
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-052
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 3 g in 227 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
ALCOHOL
FD&C BLUE NO. 1
ISOPROPYL ALCOHOL
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58503-052-01 227 g in 1 BOTTLE None
2 NDC:58503-052-02 227 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/30/2014
Labeler — China Ningbo Shangge Cosmetic Technology Corp (529287434)
Establishment
Name Address ID/FEI Operations
China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture (58503-052)

Revised: 08/2018 China Ningbo Shangge Cosmetic Technology Corp

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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