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NDC 71927-0020-01 Medicated Chest Rub 4.8; 1.2; 2.6 g/100g; g/100g; g/100g Details
Medicated Chest Rub 4.8; 1.2; 2.6 g/100g; g/100g; g/100g
Medicated Chest Rub is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Orazen Inc. The primary component is CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL.
Product Information
| NDC | 71927-0020 |
|---|---|
| Product ID | 71927-020_ecddaa3b-e190-1c74-e053-2995a90ad86a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Medicated Chest Rub |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Camphor, Menthol, Eucalyptus Oil |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 4.8; 1.2; 2.6 |
| Active Ingredient Units | g/100g; g/100g; g/100g |
| Substance Name | CAMPHOR (SYNTHETIC); EUCALYPTUS OIL; MENTHOL |
| Labeler Name | Orazen Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71927-0020-01 (71927002001)
| NDC Package Code | 71927-020-01 |
|---|---|
| Billing NDC | 71927002001 |
| Package | 50 g in 1 JAR (71927-020-01) |
| Marketing Start Date | 2022-02-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ecddaa3b-e18f-1c74-e053-2995a90ad86a Details
SPL UNCLASSIFIED SECTION
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
INGREDIENTS AND APPEARANCE
| MEDICATED CHEST RUB
camphor, menthol, eucalyptus oil cream |
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| 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) | |