OTC Medication Information: XtraCare Ice Cold Topical Analgesic Gel

XTRACARE ICE COLD TOPICAL ANALGESIC GEL- menthol gel
Rejoice International

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

XTRACARE ICE COLD TOPICAL ANALGESIC GEL menthol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-052 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:57337-052-01 227 g in 1 BOTTLE 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 — Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Operations
China Ningbo Shangge Cosmetic Technology Corp.		529287434	manufacture (57337-052)

Revised: 09/2019 Rejoice International