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NDC 72901-0002-01 Active HYDROGEN PROFESSIONAL cream 70 mg/mL Details
Active HYDROGEN PROFESSIONAL cream 70 mg/mL
Active HYDROGEN PROFESSIONAL cream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by 8.0 IDEAL BALANCE D.O.O. BEOGRAD. The primary component is MENTHOL.
Product Information
NDC | 72901-0002 |
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Product ID | 72901-002_d8cb23e6-09b9-f412-e053-2995a90a782b |
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 | Active HYDROGEN PROFESSIONAL cream |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Menthol |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 70 |
Active Ingredient Units | mg/mL |
Substance Name | MENTHOL |
Labeler Name | 8.0 IDEAL BALANCE D.O.O. BEOGRAD |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2023-12-31 |
Package
Package Images



NDC 72901-0002-01 (72901000201)
NDC Package Code | 72901-002-01 |
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Billing NDC | 72901000201 |
Package | 1 TUBE in 1 CARTON (72901-002-01) / 50 mL in 1 TUBE |
Marketing Start Date | 2019-03-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4c48acd0-4b08-4560-8fbc-3a05a7d5a57d Details
Warnings
- For external use only
- When using this product
• use only as directed
• do not bandage or use with heating pad or medicated patch
• avoid contact with eyes and mucous membranes
• do not apply to open wounds or damaged, broken or irritated skin
• a slight burning may occur upon application with disappearing effect in short period of time
Uses
Directions
SPL UNCLASSIFIED SECTION
Stop use and ask doctor if
Inactive Ingredients
Ascorbic Acid, Aqua, Boric Acid, Butylated Hydroxytoluene, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Ethylhexanoate, Disodium Edta, Glycerol, Glyceryl Stearate (and) Ceteareth-20 (and) Ceteareth-12 (and) Cetearyl Alcohol (and) Cetyl Palmitate, Magnesium Oxide, Paraffinum Liquidum, Perfume, Phenoxyethanol (and) Ethylhexylglycerin, Propylene Glycol, Tocopheryl Acetate.
INGREDIENTS AND APPEARANCE
ACTIVE HYDROGEN PROFESSIONAL CREAM
menthol cream |
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Labeler - 8.0 IDEAL BALANCE D.O.O. BEOGRAD (506132408) |