Label: ACNE RELIEF GEL- calendula officinalis, chamomilla, berberis aquafolium, hamamelis, hepar sulph. calc. , sulphur gel
- NDC Code(s): 66096-747-03
- Packager: OHM PHARMA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 29, 2021
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ACTIVE INGREDIENT
Drug Facts:
ACTIVE INGREDIENTS (HPUS*): Each 100g contains: Calendula Officinalis 1X 5g, Chamomilla 1X 3g, Berberis Aquafolium 2X 3g, Hamamelis 2X 1g, Hepar Sulph. Calc. 6X 1g, Sulphur 6X 1g.
**The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
- INDICATIONS & USAGE
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WARNINGS
WARNINGS: FOR TOPICAL USE ONLY. DO NOT APPLY TO BROKE SKIN. KEEP OUT OF REACH OF CHILDREN. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a healthcare professional. IF SWALLOWED, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE RELIEF GEL
calendula officinalis, chamomilla, berberis aquafolium, hamamelis, hepar sulph. calc. , sulphur gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-747 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 50 g MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 1 [hp_X] in 50 g BERBERIS AQUIFOLIUM ROOT BARK (UNII: VZJ9F3C3SB) (BERBERIS AQUIFOLIUM ROOT BARK - UNII:VZJ9F3C3SB) BERBERIS AQUIFOLIUM ROOT BARK 2 [hp_X] in 50 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 2 [hp_X] in 50 g CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] in 50 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 50 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-747-03 50 g in 1 TUBE; Type 0: Not a Combination Product 11/29/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/29/2018 Labeler - OHM PHARMA INC. (030572478)
