Label: MEDICATED CHEST RUB- camphor, menthol, eucalyptus oil cream
- NDC Code(s): 71927-020-01
- Packager: Orazen Inc
- 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 November 7, 2022
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Menthol 2.6% Cough supressant/Topical Analgesic
Camphor 4.8% Cough supressant/Topical Analgesic
Eucalyptus oil 1.2% Cough Supressant
Uses Temporarily relieves throat and chest
- cough
- nasal congestion due to common cold
- aching muscles
- minor aches and pains
Keep out of reach of children. In case of of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Stop use and ask a doctor if
muscle aches/pains persist for more than 7 days or come back
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. Thes could be signs of a serious condition
Warnings
For external use only
Do not use
- by mouth
- in nostrils
- on wounds or damaged skin
- with light bandages
Ask a doctor before use if you have
- asthma
- excessive phlegm (mucus)
- emphysema
- persistant or chronic cough
- cough associated with smoking
When using this product do not
- heat
- microwave
- use near open flame
- add to hot water or any container where heating water may cause splattering and result in burns
If pregnant or breat feeding, ask a health professional before use
Directions
- see important warnings under "When Using this product"
- children under 2 years of age, ask a doctor before using the product
- Adults and children 2 years and older. rub a thick layer of on chest and throat or rub on sore aching muscles. If desired cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily
- medicated chest rub
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INGREDIENTS AND APPEARANCE
MEDICATED CHEST RUB
camphor, menthol, eucalyptus oil creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71927-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4.8 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.6 g in 100 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 1.2 g in 100 g Inactive Ingredients Ingredient Name Strength CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) PARAFFIN (UNII: I9O0E3H2ZE) PETROLATUM (UNII: 4T6H12BN9U) THYMOL (UNII: 3J50XA376E) TURPENTINE (UNII: XJ6RUH0O4G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71927-020-01 50 g in 1 JAR; Type 0: Not a Combination Product 02/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/14/2022 Labeler - Orazen Inc (080916640) Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt Ltd. 726025211 manufacture(71927-020)
