Label: XTRACARE VAPORIZING CHEST RUB- camphor, menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-051-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 12, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only; avoid contact with eyes.
Do not use
- by mouth
- in nostrils
- on wounds or damaged skin
- with tight bandages
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
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.
Stop use and ask a doctor if
- muscle aches and pains persist more than 7 days or come back
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
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DOSAGE & ADMINISTRATION
Directions
- see important warnings under "When using this product"
- adults and children 2 years old and older:
- rub a thick layer on chest & throat or rub on sore aching muscles
- cover with a warm, dry cloth if desired
- keep clothing loose about throat chest to help vapors reach the nose/mouth
- repeat up to three times per 24 hours or as directed by doctor
- children under 2 years: do not use
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XTRACARE VAPORIZING CHEST RUB
camphor, menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 5 g in 113 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 113 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE OIL (UNII: C5H0QJ6V7F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58503-051-01 113 g in 1 BOTTLE; Type 0: Not a Combination Product 01/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/30/2014 Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-051)
