D-Acne (Berberis Aquifolium, Thuja Occidentalis, Calendula Officinalis) Ointment [Adven Biotech Private Limited] -

D-ACNE (BERBERIS AQUIFOLIUM, THUJA OCCIDENTALIS, CALENDULA OFFICINALIS) OINTMENT [ADVEN BIOTECH PRIVATE LIMITED]
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NDC	69825-005-01, 69825-005-02
Set ID	2efb2514-e161-09f2-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Adven Biotech Private Limited
Generic Name
Product Class
Product Number
Application Number

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DOSAGE & ADMINISTRATION

Adults: Apply externally twice daily to properly cleaned & dried affected portion.

Children under 18 years: As prescribed by the physician.
WARNINGS

If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. In case of emergency, contact a medical professional or posion control center immediately. For external use only. Replace cap tightly.
PURPOSE

Controls Acne

Skin Treatment
INACTIVE INGREDIENT

Alcohol content, Cream base
ACTIVE INGREDIENT

Berberis Aquifolium, Thuja Occidentalis, Calendula Officinalis
INDICATIONS & USAGE

Treats acne, pimples, blotches, brown spots and dark discoloration of skin. Prevents suppuration.
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

D-ACNE
berberis aquifolium, thuja occidentalis, calendula officinalis ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3)	THUJA OCCIDENTALIS ROOT	1 [hp_X] in 100 g
MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP) (MAHONIA AQUIFOLIUM ROOT - UNII:746TB9VNDP)	MAHONIA AQUIFOLIUM ROOT	1 [hp_X] in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69825-005-02	1 in 1 BOX	03/28/2016
1	NDC:69825-005-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/28/2016

Labeler - Adven Biotech Private Limited (858029164)

Name	Address	ID/FEI	Business Operations
Establishment
Adven Biotech Private Limited		858029164	relabel(69825-005) , manufacture(69825-005) , repack(69825-005)

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