dragon with arnical pain relief gel 2 oz 5621 zdp

Drug Facts

Composition & Product

Active Ingredients

menthol (4 g)

Inactive Ingredients

aloe vera leaf arnica montana flower camphor (synthetic) carbomer homopolymer, unspecified type isopropyl alcohol fd&c blue no. 1 water fd&c yellow no. 5 polysorbate 80 potassium sorbate trolamine methylparaben

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-11-23

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient Purpose

Menthol 4%.......................................................Topical analgesic

Indications and Usage

Directions

use only as directed
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
wash hands after use with cool water

Dosage and Administration

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Description

Active ingredient Purpose Menthol 4%.......................................................Topical analgesic

Section 44425-7

Other information

store at room temperature 20-25°C (68-77°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Section 50567-7

When using this product

avoid contact with eyes or mucous membranes
do not bandage tightly

Section 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions
with other ointments, creams, sprays or liniments

Section 51727-6

Inactive ingredients

Aloe Vera Leaf, Arnica Montana Flower, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Isopropyl Alcohol, Methylparaben, Polysorbate 80, Potassium sorbate, Purified water, Tocopheryl Acetate, Trolamine

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:
sprains
simple backache
arthirtis
strains bruises

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient Purpose

Menthol 4%.......................................................Topical analgesic

Indications and Usage (34067-9)

Directions

use only as directed
adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
wash hands after use with cool water

Dosage and Administration (34068-7)

Distributed by:

Genomma Lab USA, Inc.

Houston, TX 77027

Made in China

Section 44425-7 (44425-7)

Other information

store at room temperature 20-25°C (68-77°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
excessive skin irritation occurs

Section 50567-7 (50567-7)

When using this product

avoid contact with eyes or mucous membranes
do not bandage tightly

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use

on wounds or damaged skin
with a heating pad
on a child under 12 years of age with arthritis-like conditions
with other ointments, creams, sprays or liniments

Section 51727-6 (51727-6)

Inactive ingredients

Aloe Vera Leaf, Arnica Montana Flower, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Isopropyl Alcohol, Methylparaben, Polysorbate 80, Potassium sorbate, Purified water, Tocopheryl Acetate, Trolamine

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:
sprains
simple backache
arthirtis
strains bruises

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARNICA MONTANA FLOWER", "unii": "OZ0E5Y15PZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Directions use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor wash hands after use with cool water", "34068-7": "Distributed by: Genomma Lab USA, Inc. Houston, TX 77027 Made in China", "34071-1": "Warnings For external use only", "44425-7": "Other information store at room temperature 20-25°C (68-77°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50566-9": "Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occurs", "50567-7": "When using this product avoid contact with eyes or mucous membranes do not bandage tightly", "50569-3": "Ask a doctor before use if you have redness over the affected area.", "50570-1": "Do not use on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions with other ointments, creams, sprays or liniments", "51727-6": "Inactive ingredients Aloe Vera Leaf, Arnica Montana Flower, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Isopropyl Alcohol, Methylparaben, Polysorbate 80, Potassium sorbate, Purified water, Tocopheryl Acetate, Trolamine", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Uses temporarily relieves the minor aches and pains of muscles and joints associated with: sprains simple backache arthirtis strains bruises", "55106-9": "Active ingredient Purpose Menthol 4%.......................................................Topical analgesic"}